24 Jul 2020 | Regulation
In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be “an adequate level of protection” for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of...
16 Jul 2020 | MDCG
• The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020. • A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021. • ...
8 Jul 2020 | Regulation
The French notified body GMED (number 0459) has just been designated in accordance with the MDR ! It is the 15th notified body to successfully pass the designation milestone. Its designation perimeter is among the most expanded. It is available on the NANDO database...
18 May 2020 | Regulation
Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...
18 May 2020 | Quality
Current travel restrictions, combined with the necessity to maintain regulatory certification programs, have driven certification bodies to find alternative methods of assessing the conformity of medical device manufacturers’ quality management systems (QMS). Various...
