{"id":3474,"date":"2013-09-27T02:23:49","date_gmt":"2013-09-27T02:23:49","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3474"},"modified":"2013-09-27T02:23:49","modified_gmt":"2013-09-27T02:23:49","slug":"where-is-eu-headed-with-proposed-medical-device-regulations-by-envi","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/09\/27\/where-is-eu-headed-with-proposed-medical-device-regulations-by-envi\/","title":{"rendered":"Where is EU headed with Proposed Medical Device Regulations by ENVI?"},"content":{"rendered":"

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices. \u00a0Note, this issue is not set in stone\u00a0and you should read some of the detailed analysis on this topic so you are able to plan for these changes (such as start on a “living” quality plan so you are more prepared when the time comes that you will need to take required actions).<\/span><\/p>\n

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. \u00a0See the article from Eucamed on a survey they did of medical device companies in Europe<\/a><\/strong> to get an idea of the costs involved with these proposed changes. \u00a0On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament\u2019s Committee for Environment, Public Health and Food Safety (ENVI)….”\u00a0in their Article titled Rushed deal leaves patient and jobs in second place<\/a><\/strong>.<\/span><\/p>\n

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.<\/span><\/p>\n

The first of the 2 websites I read regularly is Medical Device Academy<\/a><\/strong>. \u00a0The article\u00a0provides analysis and<\/strong> interpretation of how the EU took the next step in approving the proposed medical device regulations<\/strong><\/a>. This article covers a lot of ground including the EU Commission Press Release<\/a>\u00a0<\/strong>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?<\/span><\/p>\n

The second website I am always checking up on is MedicalDeviceslegal<\/a><\/strong> 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. \u00a0He has written many articles on this specific subject and has been following the process closely. \u00a0His latest article indicates that the “ENVI vote result worst of all worlds”<\/a>. \u00a0\u00a0<\/strong>He gives you the bad news straight up.<\/span><\/p>\n

Other resources I rely on a pretty regular basis that also have articles on this subject are:\u00a0<\/span><\/p>\n