To be placed on the EU market, certain products without an intended medical purpose have to comply with the Medical Devices Regulation (MDR). Annex XVI…
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…
Switzerland: revision of MedDO for products with aesthetic functions
Similar to Annex XVI of the EU Medical Devices Regulation (MDR), since May 2021, the Swiss Medical Devices Ordinance regulates certain products that have an…
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…
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…