How to work with Annex VIII from the Medical Device Regulation (EU MDR)
EU MDR Annex XVI - Draft Common Specification [Stefan Bolleininger]
Technical documentation for CE marking as per EU MDR
Q&A on Annex XVI Products - Check transition timeline
Class 3 Medical Device EU MDR
MDCG 2023-5 on Annex XVI class
MDCG 2019-07 rev 1 on PRRC
MDCG 2023-7 on Clinical Investigation
Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements
Clinical Evaluation of Medical Devices according to EU MDR 2017 745
Italy: Custom-made medical device registration - Specific website available
Letter to EU Parliament
Annex XVI extension period
MDCG 2021-27 on Importer and Distributor
FIMEA designate first Notified Body under the IVD regulation in Finland
Medical Device & IVD regulations, impacts for MD manufacturers
How to work with Annex I from the Medical Device Regulation (EU MDR)
2章 MDR・IVDRの最新情報及び臨床評価
European Medical Device Registration Chapter 2 - Classification