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>

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.

Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively

Presenter: Leo Eisner of Eisner Safety Consultants

When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern)

Where: At your office or conference room (No travel required)

What’s it about: Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS).  Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.

In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.

Cost & Registration: Fx Conferences registration page for this event. Cost is normally $249.00 but with the Eisner Safety Consultants special discount you pay only $199.00. When checking out use the $50.00 discount code AF2009EIS.

Our Events Listing Page has events we are presenting at and also there is a listing of industry events that may interest you.

Biomedical Division Northern California Discussion Group  andSan Francisco Bay Area Chapter

Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:

• IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
• Usability and Human Factors verification, validation, and regulatory requirements
• Clinical evaluation and investigation regulatory requirements

Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG 

When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast

Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited

Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404

Eisner Safety Consultants; a leading name in providing regulatory, quality system, and product safety consulting for the medical, in-vitro diagnostic, and hi-tech industries; proudly announces the launch of its revamped and improved website.

We have kept the website simple, attractive yet easier to navigate and user-friendly. We have also added several new features including:

• A news blog focused on the medical & IVD industries specifically towards regulatory, product safety and quality systems (subscribe to RSS feed)
• Updated resources on our Weblinks and Library pages
• AdvaMed Smartbrief News
• Bookmarking and sharing services to your favorite services

Coming by Mid Sept ’09 we will add our updated newsletter service.