What is the difference between MEDDEV and MDCG? скачать в хорошем качестве

What is the difference between MEDDEV and MDCG?

Both of these are acronyms are related to CE Marking of medical devices, but do you remember what a MEDDEV is? These are the guidance documents that were created by Competent Authorities to help explain the requirements of the MDD, IVDD, and AIMD ➤ https://health.ec.europa.eu/document/... Do you know what MDCG stands for? - Medical Device Coordinating Group - #8 on page 2 of the MDR ➤ https://health.ec.europa.eu/medical-d... "(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant." Do you know the difference? - The MDCG is for the MDR and IVDR; and it both the reference to guidance documents and the acronym of the committee appointed to write them. Are MEDDEVs still valid? For now, yes. The MDD and IVDD are still valid, but in transition. Therefore, they are not obsolete just yet. If there is a MDCG on the same topic, you should align procedures and policies with the MDCG instead. Join us on November 15 for a live-streaming video on this topic and we'll answer your questions. If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: https://streamyard.com/pal/d/47901504...