SITEMAP
News
- Team-NB Revises its Position Paper on Transfer Agreement for Surveillance of ‘Legacy Devices’
- New Regulation (EU) 2024/1689 harmonising rules on artificial intelligence
- New Regulation (EU) 2024/1860 amending the Regulation (EU) 2017/745 and (EU) 2017/742
- MEET us at MEDICA-COMPAMED 2024
- Update of MDCG 2020-16 Guidance on Classification Rules for IVDs under (EU) 2017/746
- Update of MDCG 2021-5 Guidance on Standardisation of Medical Devices
- New MDCG 2024-10: Clinical Evaluation of Orphan Medical Devices
- Trends in Biological Evaluations: New Draft Version of EN ISO 10993-1
- EC updates Guideline MDCG 2022-4
- Amendment Proposal of MDR and IVDR: EU Parliament Approves Proposed Measures
- Harmonised Standards under EU MDR / IVDR: EC Publishes New Implementing Decisions (EU) 2021/1182 and (EU) 2024/817
- MDCG 2024-1-(1-4) Guidance on the vigilance system for CE-marked devices (DSVG 01-04)
- European Commission Issues Language Requirements for Medical Device Manufacturers
- Launching EU Dashboard Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices
- MDCG 2021-27, Revision 1, Guidance for Articles 13 (Importers) & 14 (Distributors)
- MDCG 2019-07 Guidance on Article 15 on the PRRC revised
- Team-NB: Position paper on medical device lifetime
- Commission Implementing Regulation 2023/2713 published
- MDCG 2022-11 revised in November 2023
- SCC team at MEDICA-COMPAMED 2023
- MDCG 2023-4 Guidance for Medical Device Software (MDSW) – Hardware combinations published
- New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
- US-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”
- Team NB publishes position paper on transfer agreement for surveillance of legacy devices
- EU Commission Issues an Addendum to MDCG 2022-18 Position Paper on Application of Article 97
- Implementing Regulation (EU) 2023/1194 on transitional provisions for Annex XVI products adopted
- MEET us at MEDICA-COMPAMED 2023
- UK MDR: GB extends the acceptance of CE marked medical devices
- Notified Body Confirmation Letter – EU 2023/607
- 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
