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

If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some major changes proposed some good and some not so good. 

The later occurred a couple weeks ago when the Rapporteur Mrs. Roth-Behrendt proposed in a draft report for the MDD regulations.  As Eucomed states “The draft report is a step backward for patients, healthcare systems and Europe.”  The reason is the report calls for “a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patient in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety.”  The system would create a “enormous bureaucratic system with no benefits.”   Note, this is not a final report so there is a ways to go before we know if this will be finalized as is or modified. 

To get more information and perspective from these organizations please read on the posts and articles: Erik Vollebregt excellent article on the draft report detailing what the changes are; a Guest blog post on Erik Vollebregt medicaldeviceslegal website titled “no enhanced patient safety resulting from rapporteur Roth-Behrendt’s proposal”; Eucomed’s position and understanding of the Rapporteur ‘s draft report; a blog post by the CEO of MedTech Europe, EDMA, & Eucomed in regard to draft report for the MDD; MedTech Europe story on “European Parliament’s ENVI Committee releases draft reports on MDD and IVDD; and Where the EU system for medical devices is and needs to go.

We hope these articles help you understand where the process stands and help you form your own opinions.  From there where you go is up to you but know we will keep sending you updates on this process as we find relevant information to pass on as this process is critical to the survival of the European Medical Device Market.

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