CE Marking: Obtaining and Maintaining EU Compliance Under the New Medical Device Directive
Held Nov. 13, 2007
While nearly all medical devices sold in the European Union (EU), the world's second largest medical device market, must carry a CE Marking, obtaining the marking can be complicated. To make matters worse, the European Parliament has recently adopted 141 amendments to its medical device directives (MDD), including software in devices, device construction and safety labeling.
Failure to understand this difficult process and the impact of the new amendments can lead to delays in approval, repeat paperwork, additional costs — or worse — outright denial of market access.
Often it is necessary to hire an authorized representative to make your case before the European Commission and a notified body must be contracted to run device testing, along with the submission of various documents — all of which may be unfamiliar to anyone outside the EU.
How can you make sense of all this and still get that CE Marking for your medical device?
Regulatory requirements expert Eric Henning will offer front-line, real-world advice on how to effectively and efficiently obtain and maintain a CE Marking. He will explain the four device categories and share what the MDD amendments mean for medical device companies entering the EU, as well as those already established.
Order now for your entire team to listen and discover:
- What makes your device a Class I, IIa, IIb or III, and what that means to you in terms of compliance burden
- Specific elements notified bodies look for in companies when assessing compliance to 93/42/EEC (MDD)
- Steps to organize a technical file that will help avoid delays or denial of CE Marking approval
- What is expected for clinical data
- The important changes in the MDD including the practical impact they will have, and when companies will likely have to comply
- Strategies to show compliance to the essential requirements (Annex I)
- Routes to conformity with the essential requirements
- Ways to ensure audits go smoothly
- Tactics for maintaining the CE Marking