MHRA is developing guidance for IVDR/MDR exemptions and streamlines services for medical device customers

The Medicines and Healthcare products Regulatory Agency (MHRA) is developing guidance for health institutions wishing to apply for the exemption to the new medical device regulation (MDR) (2017/745) and in vitro diagnostic medical device regulation (IVDR) (2017/746). The exemption is regarding Article 5 of MDR/IVDR.

The MHRA aims to gather views from a range of stakeholders. In order to get the best range of views and allow health institutions to test and model the guidance, this consultation will run until 31st March 2019.

To view the statement from the MHRA regarding the health institution exemption for MDR/IVDR, please click here.

The MHRA has also launched a new online service to support customers of the devices division, which includes device registrations and Certificates of Free Sale. The MHRA aims to have everyone on the new system by the end of February 2018. If you use the MHRA device registration service or apply for Certificates of Free Sale, you will receive information with instructions and a go-live date.

Some of the benefits of the new online service include:

  • One customer account, allowing multiple users, via a single online portal.
  • Simpler and more user friendly.
  • No need to re-register – your current registration will remain legally valid but with a new account reference number.
  • Global Medical Device Nomenclature (GMDN) – update registered devices with the GMDN.
  • Tracking, self-service functionsand enhanced data management.
  • More cost efficientcustomers will be able to register General Medical Devices and IVD devices in one registration process with only one fee.

To read more about the MHRA’s new online service for medical device customers, please click here.