MEDDEV 2.7/1 has been updated. The document is titled “Clinical Evaluation: a Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC.” While the new Revision 4 is a guideline, it does provide industry with specific information on how the Notified Bodies will be reviewing requirements for medical devices in Europe. This is a complete rewrite of the Revision 3 from 2009. And there still may be more changes to come once the new draft Medical Device Regulation (MDR) and in vitro Diagnostic Regulation (ivDR) are finalized.
You will want to carefully review the new MEDDEV 2.7/1. Some areas that are impacted by the guidance are:
- Usability – Evaluators will now review performance testing and data to support usability
- Evaluation throughout the medical device lifecycle – “Sufficient clinical evidence” of conformity during the initial acceptance phase will be supported by on-going review during PMS (Post Market Surveillance). PMS reviews will be scheduled based on risk factors and probably be more frequent.
- Qualifications for evaluators are now more stringent.
- Clinical evaluations will require proof that relevant essential requirements are being met. Use Annex 7 for guidance on this.
- Demonstration of “equivalence” has become more difficult. For any device to use alternative compliance schemes in this way, documentation will be required to show all three general criteria (Clinical, Technical, Biological) are met.
It is expected that the impact of this new MEDDEV will be more clinical evaluations over the entire lifecycle of a device, more in-depth reviews of a number of factors including usability, more highly qualified evaluators, and more reports. There is no information on when the Notified Bodies will begin exercising the new guidance in this publication. So you may want to review it soon and then check in with the organization you use for EU Certification to determine how to best update your processes, etc.
With greater scrutiny of your product and the clinical evidence for it’s efficacy and safety, you can count on added costs. Your first step will be to perform a gap analysis in order to get a handle on what lies ahead. Luckily, this new publication offers you a lot of new material to help with this task.
If you need a copy, please use our webstore, www.document-center.com, to order now. Here’s a direct link to the order page for MEDDEV 2.7/1 for your convenience. Or get in touch with our staff by phone (650-591-7600) or email (info@document-center.com). Here at Document Center Inc. our products and services help many in the medical device industry. Make us your Standards Experts!
