OSA MDR Members’ Update – May 2021

The EU Medical Devices Regulation 2017/745 takes full effect on Wednesday 26 May.

The EU MDR does not apply in Great Britain. However if you manufacture or supply medical devices in or to Northern Ireland or any EU member state, those medical devices must comply with the EU MDR.

We have provided a timeline on how regulations are applied in the UK and Europe, and links to resources from the MHRA and the European Commission.

https://www.osa-uk.co.uk/framework-and-timeline/

Unique Device Identification (UDI)

The EU MDR includes a requirement that all medical devices are assigned a UDI to make it easier to trace them when necessary. Although UDI, please note that Class 1 medical devices do not need to implement UDI until 26 May 2025. The European Commission are still working on guidance documents to clarify some aspects of UDI and EUDAMED.

The European Commission has set up a helpdesk to support economic operators in implementing the obligations and requirements of UDI. It provides support on UDI assignment, labelling and registration of devices on EUDAMED. It also provides support on the use of the European Medical Devices Nomenclature (EMDN). You can access the support desk here.

Classification of spectacles

As previously mentioned, the classification of spectacles under the EU MDR has caused some problems because they comprise two separate medical devices. The Medical Devices Coordination Group, comprising representatives of all EU Member States and chaired by a representative of the Commission has issued guidance which clarifies that spectacles are classified as “adaptable medical devices”. This means that an optician or optometrist that makes up a pair of spectacles, or a lens laboratory, will not fall take on the responsibilities of a manufacturer but will instead fall within the definition of a distributor. You can read that guidance here.  In addition, the European Council of Optometry and Optics has provided guidance for their members on how this is likely to work in practice. A  copy of that guidance is available from the OSA office.