Europe – Medical devices: EU regulations for MDR and IVDR

What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Overview

This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

Medical device types and their associated regulation

The 2 main medical devices and their associated regulations are:

You must meet the requirements in the relevant Regulation before your device can be placed on the market.

Introductory guide to MDR IVDR

We have created an interactive guide to the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) (PDF7.03MB27 pages)

Guidance for Annex XVI manufacturers

By May 2020, some products that do not have an intended medical purpose will be required to comply with the new regulations for medical devices. These groups of products are listed under Annex XVI of the Medical Device Regulations (MDR). Further information about the specific requirements of the MDR on these groups can be found in this leaflet: Guidance leaflet for products without an intended medical purpose (PDF160KB6 pages)

Placing a device on the market under the new Regulations

The Regulations ‘entered into force’ on 25 May, which is when the three- and five-year transition periods began. Therefore, the MDR and IVDR will fully apply in EU Member States from 26 May 2020 and 2022 respectively.