POST MARKET SURVEILLANCE New requirements for post market surveillance for Medical Devices.
MEDICAL DEVICE REGULATION
The long journey which has started in 2012 has finally come to an end and the long awaited text has been issued on 5th May 2017. The MDR 2017/745 will replace the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), whereas 2017/746 will be replacing 98/79/EC.
The Regulations entered into force on May 25th, 2017 . The Date of Application has been postponed to May 26th, 2021 due to the COVID-19 pandemic.
Manufacturers will have to deal with many new requirements such as;
Additional essential requirements,
New classification rules,
Detailed requirements for market surveillance (such as CER, PMCF, PMS, PSUR)
Among many others.
A long and detailed transition plan will be needed for the most of the manufacturers in order to update their technical documentation and processes to meet the new requirements.
This long awaited text which addresses concerns over the assessment of product safety and performance seems to change the structure and players of the European Medical Device Market dramatically.
The text of the MDR consists of;
101 “Whereas” paragraphs which explains why the regulation has been issued,
123 “Articles” in 10 Chapters, which list the requirements of the regulation and,
17 “Annexes”, which give very detailed information for the implementation of the regulation.
In order to have detailed information about the new requirements for your product group and set up an effective transition plan you can contact us.
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