Updates on the Ongoing guidance development within MDCG Subgroups

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance documents of the MDCG Subgroups.

Several new guidance documents have been added, related to topics such as standardisation process, artificial intelligence or Market Surveillance. Interestingly, a guidance for COVID-19 antibody tests is also in the works and it is scheduled to be endorsed before the end of the year. On the other hand, certain guidance documents have been postponed, even though most the established plan has been maintained.

You can find a summary of all the changes in the next tables.

Asphalion, an International Scientific and Regulatory Affairs Consultancy with extensive knowledge on medical devices, closely monitors every new and movement around the new MDR and IVDR in order to be able to better advise and guide manufacturers and stakeholders on their implementation. If you have any questions do not hesitate to contact us at: info@asphalion.com