This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system

As you know Risk management is a necessary, yet onerous, task when developing electro-medical devices. Since IEC 60601-1 3rd ed. was published, manufacturers have faced many new risk management challenges with respect to their electro-medical devices, especially home health devices.

Avoid the common pitfalls of risk management in IEC 60601-1 3rd ed. Experts will share case studies in their risk management practices for their own devices.

Come join us at the RAPS Convergence Conference to learn more on this subject.

On 30 April 2013 the Medicaldeviceslegal.com website via Axon Lawyers posted a really helpful new document for your use (free of charge and no request for info about you or your company).   The RAPS Dutch/Flanders chapter has been active in defining a list of EU legislation that does not directly regulate medical devices but covers them in its scope, like environmental design requirements for electronic devices.  From this listing Axon Lawyers expanded the document into an English language document that includes active links to the underlying legislative texts, the EU law summaries in the ScadPlus database, if available, and to the EU Commission web pages with explanation about the rules concerned.

Axon Lawyers mentioned that this list will always be in constant flux because these rules tend to be amended a lot.  So, the best place to download this chart is directly from their blog posting.  If you want to just download this version of the chart click here for now but check back with their website (Medicaldeviceslegal.com) to look for updates.  At this point they haven’t decided how they will distribute updates to this chart but I am sure they will figure something out and disseminate, as appropriate.  Stand tuned for more updates on this valuable resource and let’s again thank both the RAPS Dutch/Flanders chapter and Medicaldeviceslegal.com website for this resource they are sharing with us.

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully).  More information can be found on our blog post on this topic.

On March 4th  join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group).  Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry.  Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.