In May, a new guideline, MDCG 2022-8 was published on the website of the European Commission and approved by the...
Author: rapharm
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: 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...