Updates on the Medical Device Directive "Recast" and the ISO 14155 Revisions

Pharma Vies for Control of Device Regulation
Directly following the 2007 revision, the European Commission proposed a complete recast of the medical device industry, with merger of the MDD, AIMD, and IVD directives, creation of a centralized European Agency for Medical Devices, and central regulation, classification, and approval of the “highest risk” devices. The pharmaceutical associations were in favor of the overhaul, stating “the current situation of medical devices in Europe is worrying, and…the entire legal framework needs to be reinforced.” Not surprisingly, the device industry was opposed to the overhaul, stating “there is no evidence-based justification for a recast.” The issue of revision has been delayed until a new Commission is seated this summer.

And in a surprise vote, the ISO/DIS 14155 Clinical Investigation of Medical Devices for Human Subjects--Good Clinical Practices (May 2008) was voted down, with all the nay votes coming from Europe. Some countries worried that the new standard was inconsistent with the MDD recast, others worried that it was too detailed and prescriptive.

More Trials Start in Europe
It's easier to start a device trial in Europe than in the States and easier to get to market. The regulatory barrier is lower, the review barrier is lower, and CE Marks are easier to get than 510k approvals. If you have an innovative device, chances are you'll do your trials and go to market in Europe first.

Learning Objective
This course is more than theoretical, you will learn in practical terms what MDD changes were planned and which are likely to survive.

How to Stay Ahead of the Game
The recast would have changed the whole process of medical device classification, regulation and approval. Notified Bodies would play a different role, country regulatory bodies would have played a smaller role, and the power would have moved to a centralized agency. The result would have made it more difficult to conduct clinical trials in Europe and more difficult to bring devices to market. Similarly, the ISO revisions were more sweeping, and once harmonized in Europe would have made the conduct of clinical trials comparable to the States and Japan. The two events have granted a reprieve; if you are planning on European trials, now is the time to conduct them.

Dr. Bos will Discuss
[x] The changes planned in the 2008 MDD recast, why they were proposed, and how it would have affected your clinical trial plans.
[x] Why the recast was delayed.
[x] The process for amending a directive.
[x] Which changes, according to Dr. Bos' crystal ball, will survive.
[x] Why Europeans voted against the ISO/DIS 14155 of 2008.
[x] Where Europe stands now with respect to the two big issues of adverse event reporting in clinical trials and literature reviews as a path to market.

You will Receive
[x] PowerPoint slides.
[x] Understand of the rift between devices and pharma and how it could affect you.
[x] A list of MDD changes the device industry favors.
[x]A list of MDD changes the device industry does not favor.
[x] An expert speaker in Dr. Gert Bos.
[x] 0.15 CEUs and Certificate of Attendance.

Audience Suitability
[x] Sponsors of European device trials.
[x] Monitors of European device trials.
[x] Regulatory professionals.
[x] Manufacturers seeking CE Mark.

Presenter
Dr. Gert Bos is the certification manager for CE marking medical devices at KEMA Notified Body in Arnhem Area, The Netherlands, and is chairman of the notified body forum NB-MED in Brussels. He is also Vice-chair of the Notified Body Recommendations Group, NBRG. He participates in MDEG and MDEG Working Group on MRAs, TSE BSE, and New and Emerging Technologies. He specializes in regulatory affairs, European legislation in medical devices, and 510k, CE Marking, ISO 13485, and working in Japan. Dr. Bos has a PhD in biomaterials and chemical technology from Universiteit Twente in Enschede, The Netherlands.

The purchase is $424 for OnDemand access and $474 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.