Two decades after the adoption of Directive 2002/46 / EC of the European Parliament and of the Council of 10...
News
EU: Joint implementation and preparedness plan for IVDR
The Medical Device Coordination Group (MDCG) has issued a Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on in...
EU: Expert Panels on medical devices and in vitro diagnostics transferred to European Medicines Agency (EMA)
On 1 March, the Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has...
EU: Two new and one updated guideline have been published and approved by the MDCG
In February 2020, two new guidelines MDCG 2022-3 and MDCG 2022-4 and a new version of guideline MDCG 2021-21 Rev.1...
EU: On 25 January 2022, the European Parliament accepted Regulation 2022/112 amending the IVDR Regulation as regards transitional provisions for certain IVD devices and the deferred application of the conditions for in-house devices.
Regulation (EU) 2022/112 of 25 January 2022 was published in European Official Journal L 19/6 of 28 January 2022. The...
EU: New harmonized standards for MDR and IVDR regulation have been published
In the first week of January 2022, Commission Implementing Decisions (EU) 2022/6 on new harmonized standards for MDR and 2022/15...
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