How to Create a Product Safety Update Report (PSUR)
The European Union (EU) has established medical device regulations to protect the public from potentially unsafe or ineffective products
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- Jan 12, 2023
- 3 min
Time Running Out: The European Commission Extends Delay for Medical Device Regulations
The EU regulation 2017/745 (MDR) and 2017/746 (IVDR) for medical devices provide detailed protocols for the rigorous and comprehensive...
- Jul 8, 2021
- 4 min
CE MARKING for Medical Device according to the EU REGULATION (MDR/IVDR)
Technical Documentation Once we have mapped the requirements, understood the classification, coordinated expectations with the notified...
- May 31, 2021
- 3 min
How does the PRRC help meet the Unique Device Identification (UDI) System and Article 16?
The new EU regulations (MDR & IVDR) are here – hurry up to follow and adapt to the changes! According to The European Commission Q&A...
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