Recently, two new guidelines, MDCG 2022-5 and MDCG 2022-6, were published on the website of the European Commission and approved...
EU: In addition to the entry into force of previously prepared parts of legislation in the field of medicines, 2022 is marked by preparations for changes to the general regulations in the field of medicines
On 28 January 2022 new legislation in the field of veterinary medicines, entered into force, which aims to adapt regulations...
EU: European Commission begins intensive work on maximum daily levels of vitamins and minerals in food supplements
Two decades after the adoption of Directive 2002/46 / EC of the European Parliament and of the Council of 10...
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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