PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging
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.
MDR Technical documentation requirements will be one of the main challenges for
CE mark is required for each medical device sold in EU. Due
Implant card (IC) is one of the new requirements of the MDR
The ISO 14971 Risk Management standard defines principles for a risk management
ISO 13485:2016 is a quality management standard for medical devices. This standard
Food and Drug Administration (FDA) is the legal authority to establish rules
MEDICAL DEVICE SINGLE AUDIT PROGRAM The Medical Device Single Audit Program (MDSAP)
A SHORT GUIDE FOR MEDICAL DEVICE START-UPS: HOW TO CE MARK YOUR
MEDICAL DEVICE REGULATION The long journey which has started in 2012 has