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The Experts Exchange provides informed opinion and information to the Healthcare Technologies sector, from people at the the heart of it. This section also provides the opportunity to gain valuable insights from these individuals.

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Clinical Evidence For CE Marking Your Medical Device

29/10/2009 16:36:07

by Janette Benaddi, CEO of Medvance and Chair of The Institute of Clinical Research

If you are developing a new product which is regulated as a medical device you will need to generate clinical data to show that the device is safe and performs as intended.

It is not uncommon for Medical Device companies to gain CE marking without carrying out a Clinical Investigation in humans. However, a rigorous process is necessary to determine whether a Clinical Investigation is needed.

The recent amendments to the EU Medical Device Directives place greater emphasis on clinical data and the clinical evaluation process and to give companies an insight into the changes I ran two breakfast seminars at Medilink.

The two seminars took place on Wednesday 21st October and Wednesday 4th November and were a great success.

You can download my presentation from the event and download videos from the event over the next few weeks .

Attendees at the recent events can use this area to directly ask Jeannette further questions about the topic of CE Marking.

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Comments 4

Sara Mallender 23/11/2009 00:00:00
Thank you for delivering such an interesting presentation, Janette.

We are a distributor of medical products and we proactively support our manufacturers in any PMCF activities they may choose to undertake.

Please can I just ask how much clinical evidence manufacturers are required to collect during the PMCF phase, if implemented ? Are there any general guidelines that they should be working to e.g. what is considered to be an acceptable response rate to PMCF questonnaires, frequency of issue, etc. ?

I would very much appreciate any advice you can give. Thank you.

Kind regards,

Sara
Janette Benaddi 27/11/2009 00:00:00
Hi Sara
Thank you for your question and I am very pleased you found the meeting useful. Manufacturers are required to have a post market surveillance system in place. This can include a number of activities such as vigilance, questionnaires and studies. The amount of data to be collected is determined by the manufacturer depending on several factors including type of device, class of device, novelty newness, and other contributing factors. For example if it is a Class III long term implantable product then it is likely the manufacturer will wish to conduct formal post market clincial studies. If it is a Class I surgical instrument, vigilance reporting would normallly be suffcient as a PM activity. With regard to response rates to questionnaries sent out to users, the highest we have ever had has been 64% which is considered fairly high, it depends on how you structure these and what type and amount of information you are asking for. PMCF guidance is available for a small number of devices including breast implants, joint implants and some cardiovascular products. I hope this is helpful for you.
Regards
Janette
kcjnrdge 13/01/2010 00:00:00
kcjnrdge
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