As you are probably aware, EU Directive 2007/47/EC revises the Medical Devices Directives (MDD) and Active Implantable Medical Devices Directive (AIMD). In accordance with the European Commission requirements, as of 21 March 2010 medical device manufacturers, whose devices are placed on the EU market at that time, must be in compliance with either the MDD or the AIMD. Please be aware that this is the date for full implementation of these revised directives and that there is no transition period beyond this date.
Since the deadline is fast approaching, and as a service to our clients, Qserve has prepared a “Checklist” CHECKLIST to help you determine whether you are in compliance with the requirements of Directive 2007/47/EC and to identify any gaps which still need to be filled before March 21st , 2010. Please find this checklist attached. Click on: CHECKLIST
Should you require any further advice or clarification, for example:
• How your Notified Body will likely approach evaluation of your device(s) according to the new/amended requirements;
• Classification, or other issues relevant to your device; or
• If you need help with implementation of Directive 2007/47/EC; then please consider contacting us.
Qserve will be happy to perform a Gap analysis on your quality system and regulatory documents. We will provide you with a comprehensive report using our “Checklist MDD 2007/42/EC”. You can use this report to generate a corrective action plan (CAP) to help ensure compliance to the MDD 2007/47/EC. If necessary Qserve can assist you with preparing and implementing the CAP, or any of its elements. This may be especially useful for preparing the new and expanded clinical risk/benefit reports in conformance with MEDDEV 2.7, as well as with your
Post Market Clinical Follow Up (PMCF) process.
If you would like additional assistance, then please complete the attached checklist CHECKLIST and return it to Qserve at office@qservegroup.com or fax to : + 31 299 412 001. We will then contact you ASAP.
“Qserve, the Practical Approach
We Bring You to Market Faster”
As always, all of us at Qserve look forward to assisting you with your quality and regulatory compliance needs, and we hope you find the attached checklist useful.
Thank you for your attention and best regard,
The Qserve Team
Qserve Group
Europe office
T: +31 (0) 299 412 000 | F: +31 (0) 299 412001
USA office
+1 603 369 3550 | +1 877 288 9110 (Toll Free)
www.qservegroup.com
www.qservegroup.com