With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two guidance documents on Annex XVI devices. Annex XVI products are…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the manufacturer’s sole responsibility to select the appropriate class and rule…
Q&A on Annex XVI transitional period
In June 2023, the Official Journal of the European Union published the common specifications for the new legacy period of Annex XVI devices. The Medical…
PSUR under MDR: When it’s necessary, and what are the deadlines?
As part of the efforts to establish a more consistent and systematic review of post-market surveillance data by manufacturers under the new Medical Devices Regulation (MDR)…
Annex XVI MDR: new legacy period for devices without an intended medical purpose
Today, 21 June 2023, the Official Journal of the European Union published the final text for the new legacy period of Annex XVI devices. Annex…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the amendment of common specifications for products without intended medical purpose.…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on the ongoing work of the MDCG and its subgroups. You…