Medical device manufacturers are required to comply with Medical Devices (...)
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Medical device manufacturers are required to comply with Medical Devices (...)
The end of 2009 turned out to be a very prolific period for the publication (...)
In our previous edition, we published a comprehensive glossary of revisions (...)
The most important changes are the requirements of clinical data and design (...)
For many years, medical device manufacturers primarily used bar codes (...)
Vigilance reporting : Latest release to provide further guidance to the use of new MEDDEV forms to be used no later than Jan 01, 2020
2019-07-10 _ About SRN request by Notified Bodies
Guidance on Article 15 - MDR_IVDR PPRC Person Responsible for Regulatory Compliance
Using the UKCA marking if the UK leaves the EU without a deal.
GOV-UK - April 01, 2019 publishing
MHRA March 19th 2019 Update about Brexit Issues confronted to EU Com last release about (how to manage) Brexit issues.
Complementary points of views, even if some zones of confusion still exist due to the general historical and even more to the current context, as you may guess.
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