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…
MDR: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A.Ş. is overall…
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…
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.…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR). The first…
Reclassification of products without an intended medical purpose: European Commission publishes a draft act
The new draft act available on the website of the European Commission aims at regulating active products without an intended medical purpose falling under Annex…