On 14 September, two new guidelines, MDCG 2022-15 and MDCG 2021-22, were published on the website of the European Commission...
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EU: On 4 July 2022, the European Commission accepted Implementing Regulation 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices (IVDs) in accordance with Regulation (EU) 2017/746
In the document European Commission explains that for certain class D IVDs harmonised standards do not exist and since the...
EU: MDCG Position paper has been published
In June, a Position paper MDCG 2022-11 was published on the website of the European Commission and approved by the...
EU: New guideline has been published and approved by the MDCG
In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the...
EU: Evaluation of cannabidiol (CBD) as a novel food suspended
The European Food Safety Authority (EFSA) currently suspending the evaluation of CBD as a novel food, as current scientific documentation...
EU: New guideline has been published and approved by the MDCG
In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the...
EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
Switzerland participates in the internal market of the European Union through the Agreement on Mutual Recognition in relation to conformity...
EU: New harmonized standards for MDR and IVDR regulation have been published
In May 2022, Commission Implementing Decisions (EU) 2022/757 on new harmonized standards for MDR and 2022/729 on new harmonized standards...
EU: Two new guidelines have been published and approved by the MDCG
Recently, two new guidelines, MDCG 2022-5 and MDCG 2022-6, were published on the website of the European Commission and approved...
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...