Glossary›MDR
MDR
The Medical Device Regulation, Regulation (EU) 2017/745, sets the conditions under which medical devices enter and remain on the market in the European Union.
What it means
The MDR has applied since May 2021 and replaces the earlier directive. It sorts products into risk classes (I, IIa, IIb, III), requires clinical evidence, a quality management system and labelling with the UDI. It also sets out the obligations of every economic operator: manufacturers, authorised representatives, importers and distributors.
In Switzerland, the Medical Devices Ordinance (MepV) provides largely equivalent rules.
Why it matters in procurement
Healthcare facilities may only use products that meet the requirements of the MDR. Whoever sources from a third country needs an importer who takes on the associated obligations. For procurement this means conformity, labelling and registration belong to every product, not only the price.
How SANOVIO works with it
SANOVIO is registered as an importer under the MDR, checks certificates and declarations of conformity and releases every batch before shipping.