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CE Marking Collagen Based Medical Devices

Viscoelastics, wound dressings, and vascular plugs are just a few of the excellent uses of collagen in medical devices.  Prior to September, 2004, CE Marking generally was assessed by a large number of the Medical Device Notified Bodies for proof of conformance with EN 12442.

In late 2003, the European issued a new directive which imposed additional requirements on collagen product manufacturers.  Compliance with the directive, CD 2003/32/EC (MDUATD) was voluntary until 30 September 2004, and mandatory after this date.

In addition, in February, 2004, the European Commission DGIII revised a special guidance which prescribes a documented risk analysis taking the risk of transmissible spongiform encephalopathies into account.  The guidance, known as MEDDEV 2.11/Rev 1 describes in detail the special conformity assessment process required by the MDUATD to be carried out by a small subset of the over 50 Notified Bodies for Medical Devices, or the European Directorate for Quality of Medicines (EDQM).

Many Medical Device Notified Bodies did not receive accreditation for performing the new conformity assessment process.  Chances are if your NB did not get notified, it may have not bothered to tell you, the manufacturer, that to continue CE Marking after 30 Sep 2004, you would still need a conformity assessment report by another accredited NB.

CRO Group is aware of many clients who were not duly notified of the new CE Marking requirement by their NBs, and who are just beginning the process now, or are still in a review state.  If you are a manufacturer of collagen based medical devices, and you require guidance and or support to complete the MDUATD process, please contact us for more information, or request a quote for consulting.

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