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.”

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 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.

I would like to also thank Martin Schneeberg & Peter Linders for allowing me to share this with all my clients and website visitors.

Implementation of EN IEC 60601-1 3rd edition

Request for Issues

on the use of the standard for CE-conformity purposes

When the transition period was defined for EN IEC 60601-1:2006 (replacing the 1988 version with its two amendments), several questions arose. These questions were included in a FAQ document that was posted at the CENELEC web site (click here) to give all users the same interpretation[1]: (click here).

The transition period, after which only the 2006 edition will be giving presumption of conformity with the relevant Essential Requirements of the Medical Device Directive (93/42/EC), is now well underway. As an increasing number of manufacturers are implementing this version of the standard, more questions come up. In particular this is the case in conversations between manufacturers and involved authorities or Notified Bodies considering CE-conformity purposes.

In an attempt to support these discussions, and to harmonize responses, we are looking for specific matters that have arisen and that may have wider relevance. Together with regulatory experts, we will seek answers to those matters that reflect a consensus opinion of the Medical Notified Bodies. Clearly, this is not a request for technical matters, e.g., for required test conditions, but rather unclear situation. A few examples of such matters are given in the annex.

If you know of such matters, or even have experienced some yourselves, please share these. If you have reached agreement on these matters or you have proposals for the same, and wish to share: these are also very welcome. As indicated, the matters will be compiled and given to experts for sound advice, followed by scrutiny from NB-MED experts, resulting in the best available recommendations for the matters indicated. This advice will be made publicly available.

Please submit your contributions to: 60601Ed3.NBMED.issues@gmail.com. Note that not all contributions may receive individual responses. We will start work with material submitted by 30 June 2011, yet contributions after that date remain welcome. We expect first results by 30 September.

Thank you for your consideration and valuable contributions.

Martin Schneeberg (TÜV SÜD PRODUCT SERVICE, member of UK 811.1, IEC TC62A, WG14, MT28, A1PMT, IECEE RM TF)

Wolfgang Leetz (Siemens AG, Healthcare Sector, chair of DKE Division 8 (electro medical equipment, electro acoustic, ultrasound, laser), chair of COCIR Standardization Policy Focus Group)

Peter Linders (Philips Healthcare, chair of CENELEC TC 62, chair of COCIR Technical and Regulatory Affairs Committee, member of IEC/TC 62 CAG, A1PMT)

Annex – Examples of questions sought

Q1. Valid EC Design-Examination certificate period vs. DOCOPOCOSS: 2012-06-01:
Example: Suppose an MDD class IIB or III electrical medical equipment was placed on the EEA in 2009. It has a signed EC Design-Examination Certificate by a NB based on 2Ed EN 60601-1, valid until 2014-01-01 (five years).

Question: Is this product affected by the DOCOPOCOSS related to EN 60601-1:1990 (+ am1 + am2), June 1st 2012? Keep in mind that a valid EC certificate has been issued by a NB which is valid 5 years up to 2014.

Q2. Future totally new particular standards:
For a specific MEE does not exist a specific particular standard related to 2Ed EN 60601-1. However, for this specific MEE a totally new particular standard related to the 3Ed EN 60601-1:2006 is work in progress. This question is relevant at least for:
– 60601-2-63: for dental extra-oral x-ray equipment,
– 60601-2-64: light ion accelerators,
– 60601-2-65: for dental intra-oral x-ray equipment,
– 60601-2-66: hearing aids and hearing systems

Officially such MEE’s shall fulfil the complete 3Ed EN 60601-1:2006 plus the relevant particular standard 60601-2-XY at the date 2012-06-01, unless there is a specific transition period for the applicable particular standard. Usually no specific transition period for the totally new particular standards are defined in the OJ, therefore, 2012-06-01 will apply.

Is there any guidance beyond the general advice to discuss specific problems related to the application of these new standards with the NB and using Risk Management?

Can 3 years transition period for the EN 60601-2-XY be claimed starting from publishing the EN version of the particular standard?

Q3. Is ZLG paper 3.5 A1 legally binding for EU NB’s and MEE manufacturers:
The ZLG-paper 3.5 A1 addresses a valid concern extremely clear: “The missing new assessment by the manufacturer after the end of the “doc” or the missing knowledge about the existing of new harmonized standards or scientific knowhow are substantial NON-conformities. If these NON-conformities will not be adequate corrected, the certificates have to be suspended or withdrawn.”
Is this paper legally binding? Am I allowed to ignore it? In clear words: If the “doc” is over and I have not objective evidence about the new 3Ed EN 60601-1:2006 requirements in a point-by-point protocol format, is my NB forced to suspend or withdraw my CE-certificate?

[1] Collateral standards under the MDD & AIMD: CLC/TC 62 questions and answers on the EN 60601-series of standards in relation to the MDD and AIMD

Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered for a recast; also other parts of EU legislation are being revised. One of these is the RoHS Directive that regulates hazardous substances in electrical and electronic equipment (EEE) in the EU. Work on the revision started in 2008 when it was called RoHS 2 (or RoHS II). By now the revision is ready and will be presented as “RoHS Recast,” because the existing directive will be repealed and replaced rather than simply amended.

Utilizing the EU’s New Approach and New Legislative Framework, the new directive will move specification of restricted substances and covered EEE to the Annexes so that they can be easily “adapted to technical progress” (ATP). The CE mark will be required for compliance; procedures for conformity assessment are specified; and standards developed by European Standards Organizations are utilized.  The European Parliament adopted the “consolidated text” for RoHS Recast late 2010, and the final step to approve legislation in the Council of the European Union is very near.

The change will significantly impact the medical device field. Where currently all medical devices and IVDs are exempt from the directive, the automatic exclusion from RoHS will disappear for MDD and IVDD devices, while it remains in place for active implants under AIMDD. The new legislation has foreseen various transition times. Medical devices, as well as monitoring and control instruments, must comply within three years after publication in the EU Official Journal, whereas IVDs must comply within five years.

The six original RoHS substances (lead, mercury, cadmium, hexavalent chromium, PBB and PBDE as identified in RoHS Annex II) are still the only ones restricted, and no changes were made to their allowed concentrations.  However, future additions to the list remain likely. The Environmental Committee report recommended that brominated flame retardants, chlorinated flame retardants, PVC, chlorinated plasticizers, DEHP, BBP, and DBP be restricted. The COR Committee opinion expressed regret that HBCDD, DEHP, BBP, and DBP were not included. Moreover, a full evaluation of the new Annex II, specifying the banned substances, is required in three years.

It is possible for individual manufacturers to apply for specific exemptions. (Specific procedures have been set up to grant the information; annex V or RoHS recast provides details.)  A list of exemptions granted for 7 years exists. The application needs to be submitted before 2014, realizing that the renewal to exemptions has to be sent 18 months before the deadline.

If no exemption is successfully obtained, then to comply with the Directive the manufacturer will need to set up a self-declaration of conformity referring to the RoHS. In order to do so, manufacturers must maintain technical documentation, cite relevant harmonized standards, implement internal production controls, and keep a register of nonconforming products. CE mark is required on the finished product, as well as manufacturer’s name, trademark, contact address, and a type, batch or serial number (to facilitate recalls) should be present on the labelling.  The EC Declaration of Conformity (specified in annex VI) that accompanies the finished product should be in the language of the local market. In the event that the product is manufactured outside the EU, then the EU importer who will share the responsibility for compliance with the manufacturer is also needed.

The EU Commission website to monitor for news of the recast of RoHS Directive is:http://ec.europa.eu/environment/waste/weee/index_en.htm

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.

This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008.  EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.

The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

The newest document has added in a few critical issues including

• that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012.  This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.
• devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.
• For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.  If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.
• and more CENELEC site link

The document is an update to the current posted document issued 9 October 2009 on the CENELEC site

The newest document will add in a few critical issues including

• that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give ‘presumption of conformity’ with the European directives covered as of 1 June 2012.  This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.
• devices should not be presumed to be unsafe simply because they were designed to comply with EN 60601-1:1990 when first introduced into the European market. Whether or not the safety of such devices represents the “state of the art” can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.
• For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive.  If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (‘superseded’) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.
• and more to be seen when issued on the CENELEC website.  I will post the link to the new FAQ when it is published.

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

CENELEC has issued a FAQs page on their website to clarify many of the confusing issues surrounding the EN60601 series of standards including the general (or base standard EN60601-1), the collateral standards (e.g. EN60601-1-XX), and the particular standards (e.g. EN60601-2-XX).  The FAQs page includes clarification on transition dates for these standards.  To go to the CENELEC website FAQs page click here.