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Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below.  A brief note of significant points is provided.

-        MEDDEV 2.12/1 Medical devices vigilance system (UPDATED – March 2012):

o   Changes that will likely affect your current procedures are:

§  2 new report forms (Annex 7 – Trend Report Form and Annex 6 – Periodic Summary Report Form), and
§  updates to 2 existing report forms (Annex 3 – Incident Report Form and Annex 4 – FSCA Form).

o   The revised guidance is applicable as of 15JUN12.
o   Overall, the content of the guidance has not changed significantly.  Minor changes appear in Section 4.5 – EUDAMED, Section 4.18 – Trend Reporting, Section 5.1.2 – Summary Reporting, Section 5.1.3.6 – Negligible Likelihood, Section 5.1.4 – Trend Reports, Section 6.3.1 – Circumstances (Coordinating NCA), Section 6.3.5 – Information between NCAs, Annex 1 – Examples, Annex 2 – Extracts from Directives, and Annex – GHTF Documents Used.  The numbering of some Annexes has changed.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf.  Also see the Manufacturer Incident Report (MIR), http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf; How to Use the MIR, http://ec.europa.eu/health/medical-devices/files/meddev/mir_use_en.pdf; and Field Safety Corrective Action report form, Field Safety Corrective Action.

-        MEDDEV 2.12/2 Post Market Clinical Follow-up (PMCF) studies (NEW):

o   Guidance provides insights into when a PMCF study should be considered, general principles for conducting a PMCF study, use of PMCF study data, and the role of the Notified Body.
o   The Notified Body is now required to “verify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices”.  Any plan to justify no PMCF study in this case should be reviewed with your Notified Body at the earliest date possible.
o   Note that incidents that occur during PMCF studies conducted with CE marked devices within their intended uses are subject to Vigilance reporting requirements.
o   The guidance does not apply to IVD devices.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_2_ol_en.pdf. 

-        MEDDEV 2.5/10 Guideline for Authorised Representatives (NEW – January 2012) [only applies with the manufacturer is outside the EU]:

o   Guidance clarifies what the Representative is required to do (e.g., keep Declarations of Conformity and Technical Documentation at the disposal of the national authorities) and discusses what the Representative may be requested to do.
o   It also clarifies that a Representative is required for devices intended for clinical investigations.
o   Per the guidance, a contract is considered vital.  I recommend that you review the current contract with your Representative to ensure that all points noted in this guidance are addressed in the contract.
o   Available at http://ec.europa.eu/health/medical-devices/files/meddev/2_5_10_ol_en.pdf.

 -        MEDDEV 2.1/6 Qualification and Classification of stand alone software (NEW – January 2012):

o   Guidance walks you through how to determine if software is a standalone device.
o   It also describes how to determine its MDD classification or select the IVDD Annex.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.

 -        MEDDEV 2.14/1 IVD Medical Device Borderline and Classification issues. A guide for manufacturers and notified bodies (UPDATED – January 2012):

o   Guidance walks you through:

§  deciding whether a device is a general laboratory or IVD device;
§  deciding whether a device falls under the IVDD or MDD; as well as
§  addressing kits that contain IVD devices, medical devices and other components.

     The manufacturer’s stated intended use is key to addressing these issues.

o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_1_rev2_ol_en.pdf.

-        MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (NEW – January 2012):

o   Guidance discusses how to determine, based on mode of action, when IVF/ART products fall under the MDD.
o   It describes issues to consider to address each MDD essential requirements along with most market considerations for traceability, vigilance, post-market clinical follow-up, and design modifications.
o   It also walks you through how to determine classification (usually Class III per Rule 13 as most incorporate one or more medicinal products).
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4_ol_en.pdf. 

-        MEDDEV 1.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP (NEW – January 2012):

o   Guidance is specific to variant Creutzfeldt-Jakob Disease (vCJD) [CJD is commonly called “mad cow” disease].
o   As the current Common Technical Specifications (CTS) cannot be adapted easily to vCJD assays, the guidance identifies basic quality requirements for vCJD assays.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_14_4_ol_en.pdf.

The full list of MEDDEVs is available at http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.  

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The next 2 blog postings are thx to Erik Vollebregt who is a Life Sciences and IP (Intellectual Property) lawyer based in Amsterdam and is one of the founding partners of Axon Lawyers.  His posting is titled:

+ New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced
+ New MEDDEV on authorised representatives: everything you know is wrong

Erik has a blog that I visit frequently for EU MDD & AIMDD information.  Erik & I communicate on occasion to discuss various EU issues related around the EU MDD & AIMDD.  He has been a great resource of information to Eisner Safety Consultants.  

The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012.  Here’s a general summary:

• The directive does not cover IVDD devices which have their own guidance document.
• In general, an e-IFU is allowed for:
• AIMDD and MDD devices intended exclusively for professional use where use by other persons is not reasonably foreseeable.
• MDD device fitted with a built-in system visually displaying the instructions for use.
• It is important to read the full requirements.  Below is a summary of some key items.
• A documented risk analysis is required covering at least the items listed in Article 4 of the e-IFU directive (intended users’ access to hardware and software to view the e-IFU, intended use environment and access to e-IFU at time of use, etc.).  BSI provided a link, e-IFU REGULATION RISK ASSESSMENT SURVEY, to a general survey which may help avoid the need to run individual surveys.  As with all risk analyses, it must be updated based on experience from the post-marketing phase.
• Information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device must be provided with the device.  The information may be on the device or on a leaflet sent with the device.
• Instructions must remain available:
• For 2 years after the expiry date of the last produced device.
• For 15 years after the last device has been manufactured for:
• Devices without an expiry date.
• Implantable devices.
• There are specific requirements when the e-IFU is available through a website such as server downtime and display errors must be reduced as far as possible, and access must meet directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 
• Hardcopy of the IFU must be provided no later than 7 days from request and at no charge to the user.
• As of March 2013, the Notified Body will need to review compliance (with the exception of Class I MDD devices).

Additional requirements may apply to specific devices based on relevant standards.  For example, from EN 60601-1:2006 (same as IEC 60601-1:2005):

• For medical devices, clause 7.9.1 states, “ACCOMPANYING DOCUMENTS may be provided electronically, e.g. electronic file format on CDROM.  If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT PROCESS shall include consideration of which information also needs to be provided as hard copy or as markings on the ME EQUIPMENT, e.g. to cover emergency operation.”
• For medical systems, clause 16.2 states, “NOTE ACCOMPANYING DOCUMENTS can be provided electronically, e.g. electronic file format or CD-ROM, for an ME SYSTEM capable of displaying or printing those documents.”

Currently, HC recognizes both 2nd & 3rd edition of IEC 60601-1.  Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.).  This doesn’t work well as there are some Particular standards that aren’t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven’t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral & Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards.  That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.

So, this HC guidance document sets out the following for the transition rules to be applied as of June 1, 2012:

1. If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.
2. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).
   NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2.  If it is after June 1, 2009n then use item 3.
3. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply.  During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).  
   Refer to NOTE in item 2. 

These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won’t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application.  HC doesn’t require meeting the ‘state of the art’ in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.

You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.

Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular & Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 – 3 above) prescribe IEC 60601-1:2005 & applicable standards.  The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.

The guidance document does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device. 

A very important note is stated near the end of the document which says:

” A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the Medical Devices Regulations.  Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the Regulations.  For further information regarding these requirements, contact the applicable regulatory authorities.  A listing of some such authorities is available at: http://www.csa.ca/cm/ca/en/community/electrical/regulators.”

I (as a medical device consultant, US TAG member of IEC SC 62A & 62D & Convener of SC62D JWG9 {IEC/ISO/AAMI/CENELEC 80601-2-58} and a Notified Body Auditor) am really pleased to see the extremely hard work that has gone into this document and also in the value that it will pass on to all the stakeholders.  There are many stakeholders that were involved in this process including Notified Bodies, NB-MED EN 60601-1:2006 issues team (Thank you for your hard work.), NB-MED, Manufacturers, OEMs, Power Supply Manufacturers, Standards Developers for EN & IEC & other national standards bodies, Test Houses, Consultants, other countries regulatory bodies (i.e. FDA, Health Canada, etc.) and more.  By use of so many different stakeholders that submitted some of these and other questions this document has a much more consistent view on the implementation issues with the complexity of a series of more than 60+ EN 60601 standards.  It is expected that this document will get revised again but when that will happen is not clear at this time.  I would assume once Amendment 1 (A1) to EN / IEC 60601-1:2006 / 2005 is released approximately end of 2012 / Sept 2012 there will be more implementation questions in addition to the ones in section 3.9 (Q & A 3.9.1 thru 3.9.5 related to A1) of this excellent resource.

This document is good for learning about your specific implementation issue(s) or if you have the time I would highly recommend reading the whole document, as this will help you understand the intricacies of some of the situations of implementing EN 60601-1 with respect to the MDD (I’m sure there are more issues but a good portion have been captured by this first version).  I believe this document would be of great help to implement similar guidance documents for many other national medical device regulatory agencies around the world that are transitioning to the 3rd edition of IEC 60601-1:2005 (or their national version of the standard).

The Table of Contents gives a good glimpse into the realm of the issues covered in this document and covers the following topics.  I also provide a further glimpse into the document by summarizing some of the specific issues within those sections (these are the indents furthest to the right):

• History (background of how we got to this point and document)
• Introduction (Section 1 – document intended to clarify many questions as related to implementation of EN 60601-1:2006 within the EU under the MDD)
• Abbreviations (Section 2)
• Questions and Answers (Section 3 – Primary purpose of the document)
• Process how to place products on the EU market (Section 3.1)
• Explain ‘placing med dvc on the market’ in EU; If med dvc doesn’t change, regulation hasn’t changed, why need provide different evidence with new Harmonized Std; are harmonized stds mandatory; do you have to retest to 3rd ed, when product been on the market for years;  why bother with transition date 1 June 2012 when my EC certificate has a 2014 expiration date; does the product in a distribution center equal ‘placed on the market’; Medical Electrical Equipment(MEE)  met 2nd ed. & breaks down after transition period what std applies now for replacement MEE; why does EU require 3rd ed. compliance with new & legacy products;

• Transition process in general (Section 3.2)
• Is use of newest Harmonized stds even if product hasn’t changed after transition date; Would it have been better to have all the stds in the 60601 series have the same transition period; Is there the bandwidth for all the testing that will be required by the EN 60601-1:2006 deadline of 1 June 2012 (for only 3rd ed. without particular stds) that it may hit a critical point;
• Application of EN 60601-1 (Section 3.3)
• Does EN 60601-1:2006 apply to AIMD products; Are mechanical rqrts of 3rd ed. applicable to non-active products; power supply questions – external pwr supply compliant to 2nd ed., pwr supply approved against EN 60950 (ITE equipment), pwr supply part of a complete 2nd ed. compliant medical electrical equipment, my pwr supply mfr isn’t ready for 3rd ed. yet – my options; What do if applying to several countries and the other country(ies) requires 2nd ed. vs 3rd ed. in EU; EN 62304 in relation to 3rd ed. of EN 60601-1; software development issues; if for some reason major redesign needed to meet 3rd ed. are there smart ways to deal with this; how obtain test protocol TRF version G of 3rd ed.; is there a 3rd ed. delta list available for evaluation of an approved 2nd ed. product
• Role of collateral standards (Section 3.4)
• Are Harmonized Standards binding; what happens to collateral stds (i.e. EN 60601-1-XX) that have been integrated into 3rd ed. of 60601-1; how deal with collateral stds that don’t have an edition aligned with 2nd ed. of EN 60601-1 (i.e. EN 60601-1-11 & -1-12)
• Role of particular standards (multiple or late particulars) (Section 3.5)
•  multiple stds related to x-ray; if x-ray equipment has interventional & non-interventional procedures do both EN 60601-2-43 & -2-54 apply; some particular stds that don’t references 3rd ed. of 60601-1 what happens then; is compliance with 3rd ed. required after 1 June 2012 even if part 2 std won’t be released til after transition period; how deal with EN 13544-1:2007 + A1:2009 which is aligned with 2nd ed. of EN 60601-1 and currently there is no development of a 2nd ed. of EN 13544-1; van every kind of IEC or ISO std act as a particular std
• Transition period of EN 60601-1:2006 (Section 3.6)
• Should there be a 3 year transition period for brand new particular standards Harmonized per the Directive {i.e. EN 60601-2-XX}; particular stds with a transition period ending after 1 June 2012; transition date known for EN 60601-2-49; transition issues with EN 60601-2-43; how deal with EN 60601-2-2 & -2-10 which have different transition dates
• Duties of Notified Bodies (Section 3.7)
• ZLG paper 3.5 A1; How an N.B. audit of technical file or design dossier of product that hasn’t started the process, or plan set-up but not start testing, or partially start testing
• Application of Risk Management (Section 3.8)
•  What are the different roles of the applicable stakeholders in this process including the mfr., Notified Body, test house, etc.; equivalent safety (clause 4.5 of 60601-1 3rd ed.); how to deal with the differences between EN 14971:2001 (equivalent to ISO 14971:2000) and EN 14971:2007; mapping rev. G of TRF  for IEC 60601-1:2005 with Risk Management documentation that is required per EN 60601-1:2006
• Amendment 1 related questions (Section 3.9)
• Amendment 1 of 3rd edition of IEC & EN 60601-1 will be published approximately Sept 2012 & around end of 2012.  This is a major amendment with more than 100 changes some very minor and some that will mean more work for the manufacturers to prove compliance and some changes that will benefit the manufacturer.  It is recommended to review the A1 as soon as you can get your hands on it to see what type of impact it will have on you.
• References (Section 4)
• Recommendation for usage (Section 5)
• Applicability of horizontal and role of particular standards (multiple or late particulars) for use in combination with IEC/EN 60601-1, 3rd.ed with respect to X-ray equipment (Annex 1)
• General – applicability of standards (Annex 1, section 1)
• Categorization of X-ray equipment related to its intended use and applicable standards (status 2012-01-20) (Annex 1, Section 2)
• Summary (Annex 1, Section 3)

European Commission – Press release

Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants

Brussels, 2 February 2012 – Following today’s publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a “stress test” of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012.

Health and Consumers Commissioner, John Dalli said: “In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case”. To add : “Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased”. To conclude : “We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.

The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon.

Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.

With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

SCENIHR concluded on the basis of available data, that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.

Next steps

First, the European Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States.

Second, the Commission will discuss with the Member States how surveillance of the medical devices can be reinforced immediately within the existing legislative framework. These issues could include further recourse to unannounced inspections, enhanced controls of notified bodies and additional sample testing on products already on the market.

Third, the Commission is also conducting a stress test in order to identify how best the questions raised by this issue can be addressed in the upcoming revision of the legislation on medical devices which was already underway. The Commission still envisages adopting a proposal on the revision of the Medical Devices legislation in the course of this semester.

National health authorities in the Health Security Committee convene by audio conference today to discuss the follow up to the Opinion.

Background

Breast implants fall under the European legislation on medical devices1. This legislation requires that, before placing such devices on the market, the manufacturers must carry out an assessment to ensure that their devices fulfil the relevant legal requirements, and in particular that their devices will not compromise patient safety. For high risk devices, such as breast implants, a third party conformity assessment body, so-called notified body, is involved in the conformity assessment procedure.

In the present case, an investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010.

On the basis of available data, it is estimated that around 400 000 PIP silicone breast implants were sold worldwide. These implants were available in nearly all European Union Member States – in particular they were widely used in the United-Kingdom, France, Spain and Germany, where respectively around 40.000, 30.000, 10.000 and 7.500 women were implanted with PIP silicone breast implants.

Work of the SCENIHR

SCENIHR is an independent advisory body established by the Commission. Its members are chosen on the basis of scientific excellence and they advise the Commission on issues associated with new and emerging health risks.

The current rapid opinion drew on top international scientists’ expertise in fields of plastic surgery, polymer science, senology and medical epidemiology.

To see the full scientific opinion on the safety of PIP breast implants, see

http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm

Link to Medical Devices Directive:

http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

1 :
OJ L 169, 12.7.1993, p. 1

The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.

Final publication and entry into force is expected at the beginning of 2012.”

Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are:

1) Substantial progress has been made over the last couple months on the document

2) The NB-MED has presented their observations and comments on the proposed document to the team proposal early in Dec 2011

3) The team has worked on integrating the observations and responding to the comments

4) on 13 Jan 2012 the group forwarded their results to the NB MED working group for their approval (validation).

5) It is expected that this document will formally be published hopefully within a couple of weeks not months.

For more details on this DRAFT document please go to http://wwww.EisnerSafety.com/draft-results-implementation-of-3ed-en60601-series-for-ce-marking/ for a copy of the DRAFT document and
http://www.eisnersafety.com/eu-en-iec60601-1-3rd-ed-request-for-issues-on-the-use-of-the-std-for-ce-conformity/ for the first announcement about this process.

Innovation Pathway

Background on CDRH Innovation

On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices in a way that maintains or improves patient safety and is based on sound science.

As part of that Initiative, the FDA proposed the Innovation Pathway, a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery. The FDA also announced a pilot submission — a brain-controlled, upper-extremity prosthetic — for review under the Pathway.

After considering public comments received on the Innovation Initiative — and extensive review of our experience from the pilot submission, the FDA is introducing the Innovation Challenge, a call for voluntary submission of innovative device applications for End-Stage Renal Disease (ESRD).

Regulatory decisions that improve patient access to safe and effective,
 innovative medical devices

Developing a New Approach to Device Review
Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

Developing a New Approach to Device Review

Developing the Innovation Pathway is an evolving process that entails the FDA approaching medical device review using new paradigms — rapidly testing them, applying what works and learning from what doesn’t. A team of experts are analyzing each step of the premarket pathways for medical devices and exploring ways to bring about more patient-centric, predictable and swifter decisions that can also address the unique scientific challenges that innovative technology often brings. The team has begun developing new tools and processes, including:

• A decision-framing tool to help reviewers and sponsors quickly determine product classification and regulatory direction;
• A decision-framing tool to help reviewers and sponsors determine requirements for first-in-human clinical trials; and
• A collaborative workspace where FDA staff, medical device developers, patients, scientists and industry can discuss the technology, intended use and the unmet public health need.

These tools, and others in development, present the FDA with the opportunity to commit its time and resources much earlier in product development. By front-loading these resources, the FDA can identify and resolve new scientific and regulatory challenges that may accompany an emerging technology that raises new or novel scientific questions. As a result, patients will receive safe and effective products more quickly and device makers can bring important technologies to market more predictably, faster, and at a lower cost.

In order to use and evaluate the new tools and processes, the FDA is inviting innovators who have ideas for medical devices that diagnose or treat End-Stage Renal Disease (ESRD) to volunteer for our Innovation Challenge. When proven successful, the FDA plans to integrate these new approaches into its other premarket programs when applicable.

Additional Information

• Driving Biomedical Innovation: Initiatives for Improving Products for Patients
• Medical Device Innovation Initiative White Paper
• Public Workshop: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010/li>

Check it out here

In the Eucomed 18 Nov 2011 newsletter article they say “In March 2011, the regulatory authorities of the … GHTF took the decision to disband the GHTF … to be replaced by a ‘regulator-led harmonisation and collaboration group.’ … regulatory authorities felt that it was time to change the way the GHTF was operating so as to accelerate international medical device regulatory harmonisation.

For more details see the Eucomed newsletter article.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

There is a video demonstration of the CardioTeach™ iPad app

Apple AppStore iPad link for the CardioTeach™

On October 1, 2011 the DRAFT “FAQ related to Implementation of EN 60601-1:2006 Clarification of open issues” was issued and this DRAFT document is being sent to NB-MED for commenting on the document.  NB-MED is also known as TEAM NB.  This organization is the European Association of Notified Bodies for Medical Devices which covers the MDD (93/42/EEC), AIMDD (90/385/EEC), and IVDD (98/79/EC).  This group publishes guidances that are agreed on by the Medical Device Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Notified Bodies. Once all the responses are agreed to it is anticipated that the document will be released as an NB-MED guidance document.

The History of this DRAFT document is restated below.  Note that any “click here” links are not live in the below text but are live in the actual DRAFT document.

History

During spring 2011, it was realized that the use of EN 60601-1 and its many family members in demonstrating compliance with the relevant and applicable requirements of the European medical device regulatory framework was not too trivial. While relevant guidance on the matter had been published at the CENELEC website as a Q&A document (click here), some Notified Bodies were giving advice that was felt to be not in line with that guidance. On other occasions, questions were raised that were not covered in the guidance.

So, it was concluded that the situation for electrical equipment in medical practice was not totally clear and that additional guidance would be useful. Further contact with the chair of the NB-MED confirmed this desirability, and a small group of experts was established. This group developed an enquiry asking for “practical issues in the implementation”, that was sent to many stakeholders in June 2011(see Annex 1). Also at the international level of IEC the request was distributed (62A/769/INF).

The response to the request was beyond expectation and the small team of experts, initially consisting of three, was expanded with Dr. Klaus Neuder of DKE (Frankfurt, Germany).

End of July 2011, the work on digesting the issues submitted until then started and it took until end of September 2011 until all material had been thoroughly discussed and answers formulated to the questions that were raised. In some cases, the questions were slightly amended to make them a little more general, and a few additional “connecting” questions were developed by the team.

It is believed that the answers, developed in close team cooperation, present a fair response to the issues brought forward and that they can be used as a reference for all stakeholders.

Now it is time for the NB-MED to scrutinize the proposed responses and see if they are also acceptable to all members of NB-MED. The NB-MED comments are kindly awaited by the end of October 2011, at the same e-mail address that was used for the initial submission of the issues: 60601Ed3.NBMED.issues@gmail.com, using the form supplied together with this document.

Happy reading!

The 60601-1 Issues Team:

Dr. Wolfgang Leetz, Dr. Peter Linders Dr. Klaus Neuder Mr. Martin Schneeberg

The Notes and summary of the Report are repeated below:

Notes:

The report is written with a multiplicity of audiences in mind. First and foremost it is intended to inform the Management Board of the European Chemicals Agency (ECHA) and the Competent Authorities on REACH And Classification And Labeling (CARACAL) of the work of the DCG. It is though also intended to provide a transparent account to other interested parties, in particular national and EU industry organisations and their members, non governmental organisations representing workers, consumers and the environment and similar organisations in third countries interested in REACH and CLP.

This report has been agreed by the members of the Directors’ Contact Group.

Summary

The adoption of Regulation (EC) No 1907/2006 of the European Parliament and the Council on 18 December 2006 concerning the Registration, Evaluation and Authorisation of Chemicals (REACH) marked a milestone in the modernisation of the European chemicals legislation. REACH is widely recognised as being the most ambitious and comprehensive piece of chemicals legislation in the world.

REACH set 30 November 2010 as the deadline for all manufacturers and importers of high volume substances and substances of particular concern to register their chemicals, thus subjecting a large proportion of the volume of chemicals on the EU market to the REACH rules.

Recognising that fulfilling the REACH requirements by this deadline would present significant challenges to industry, the Commission invited six industry organisations and the European Chemicals Agency (ECHA) to nominate members to and thereby set up the Directors’ Contact Group (DCG). The purpose of the DCG was to monitor progress towards meeting the first registration deadline and to reduce practical obstacles to registration identified by industry.

In the course of 2010 the DCG identified and addressed in total 28 issues, contributing to the successful completion of registration by the first deadline. The practical co-operation between the Commission, ECHA and industry associations therefore proved successful, demonstrating that obstacles to registration can be reduced. This clear learning from the efforts in 2010 made the Commission decide to continue the work of the DCG with the aim of continuing the registration success story through the next major registration deadline of 31 May 2013.

The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.

As an overview:

-   Scope:

• • Medical devices (per 93/42/EEC) and IVD devices (per 90/385/EEC) are now included.  They are both part of the general group called “medical devices” in the directive.
  • Active implantable medical devices remain excluded from the requirements of the directive.

-   Limits: The maximum concentrations in homogenous materials are limited, by weight:

• • Lead (0.1 %)
  • Mercury (0.1 %)
  • Cadmium (0.01 %)
  • Hexavalent chromium (0.1 %)
  • Polybrominated biphenyls (PBB) (0.1 %)
  • Polybrominated diphenyl ethers (PBDE) (0.1 %)

-   Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from

• • 22 July 2014 for Medical Devices.
  • 22 July 2016 for In-Vitro Diagnostic Medical Devices.

NOTE:  A single CE mark and declaration are acceptable.  (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)

-   Exemptions:

• • Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
  • Exemptions available to all devices are listed in Annex III.  Specific exemptions for medical devices are listed in Annex IV.
  • Exemptions for medical devices will be valid for up to 7 years.
  • Requests for exemptions:

• • • Will be filed with the Commission and include all information listed in Annex V.  Most notably, the request must include an analysis of possible alternative substances, materials or designs.
    • Renewals must be requested at least 18 months before the existing exemption expires.
    • Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health and consumer safety impacts.

-   Labeling: The labeling requirements are likely already addressed by MDD or IVDD requirements.  However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.

–   Record Retention:

• • Records must be retained for 10 years after a device is placed on the market.  Note that this may be longer than required by the MDD or IVDD.
  • Records to retain include:
    • Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,
    • List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and
    • List of  any economic operator to whom you have supplied any electrical or electronic equipment.

If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the  BSI article that is posted on our website.

Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC’s or the total composition information for each component and in turn the full product composition.  Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.

Please contact us if you have questions or concerns.