- Jul 30, 2020
Europe - May 2020
Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by...
- Jun 30, 2020
EU: MDR delayed to 26 May 2021
Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in...
- Jan 31, 2020
EU 2020 MDR Guidance Notes For Class I Manufacturers
There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the...
- Jan 21, 2020
EU: Symbols Guidance for MDR
To comply with new MDR requirements in an efficient manner before the relevant international standard is available, MedTech Europe...
- Dec 4, 2019
Europe - Nov/Dec 2019
EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...
- Nov 7, 2019
EUDAMED delay for 2 years
It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two...
- Aug 30, 2019
Europe - Aug 2019
Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...
- Aug 30, 2019
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
- Jun 28, 2019
Get Ready EU MDR: Factsheet & Step By Step Guide for Manufacturers of Medical Devices, FAQ
Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...
- Jun 28, 2019
Get Ready EU IVDR: Factsheet & Step By Step Guide for Manufacturers of in vitro Diagnostic Medi
Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period...