MHRA Issues Guidance on Device Manufacturer Registration

The UK’s Medicines and Health products Regulatory Agency (MHRA) has issued new guidance on how to register a device manufacturer or authorized representative with the agency in order to sell devices and IVDs.

Entities seeking to register must inform the MHRA if they intend to sell, lease, lend, or gift:

• A class I device it has manufactured;
• A class I device it refurbished or re-labelled;
• Any system or procedure pack containing at least one medical device;
• Custom-made devices;
• An IVD the entity has manufactured; or
• An IVD undergoing a performance evaluation.

The manufacturer must ensure that all Class I devices comply with the relevant requirements of the EU Medical Device Directive and obtain CE markings.

The MHRA does not register Class IIa, IIb, III, or active implantable devices. For these, the manufacturer must follow the appropriate conformity assessment route, which includes being assessed by a notified body.

Manufacturers without a place of business in the EU must appoint an authorized representative in the EU before marketing a device.

Read the guidance here: www.fdanews.com/04-05-17-MHRAguidance.pdf.