SITEMAP
News
- MDCG 2020-3 Rev.1: Guidance on significant changes to transitional provisions under Article 120 MDR revised
- Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD
- Team-NB revises the best practice guidance for the submission of technical documentation for medical devices
- gempex and SCC– partnership for medical device industry
- European Commission extends MDR transition period
- MDCG guidance on classification rules for IVDs revised
- New MDCG guidance – questions and answers on vigilance terms and concepts according to MDR available
- MDCG guidance on application of MDR Article 5(5) to in-house medical devices published
- Commission implementing regulation (EU) 2022/2346 and 2022/2347 regarding MDR published
- EU commission adopted proposal for a longer transition period to adapt to MDR
- Guidance on appropriate surveillance regarding the transitional provisions under MDR Art.120 revised
- Guidance on periodic safety update report according to MDR published
- MDCG published performance study application/ notification documents under IVDR
- Manual on borderline and classification for medical devices under MDR and IVDR published
- MDCG publishes position paper on the application of Article 97 MDR to legacy devices
- MDCG revises guidance document on safety reporting in clinical investigations
- IMDRF publishes guidance documents on personalized medical devices for comment
- MDCG updates joint implementation plan for IVDR
- SCC Team at MEDICA-COMPAMED 2022
- Meet SCC at MEDICA-COMPAMED 2022
- Release of a new MDCG document
- Best practice guidance for the submission of technical documentation under Annex II and III of the MDR
- New position paper on the class D measures in the absence of EURLs
- New position paper on cyber security of medical devices
- New position paper on “off-label” data
- New position paper on Transfer Agreement
- EUDAMED obligation for modules 2 and 3 postponed by one year
- The EU Commission has revised the Nanomaterial Definition
