Several guidance documents have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020 and subsequently, including guidelines on the UK Responsible Person (UKRP) and UK product registrations, intended to help medical device companies to follow the new system and continue to reach the market.
Medical device and IVD manufacturers not resident in the UK have to engage a UKRP as soon as possible. Product registrations for products placed on the market in Great Britain must be done in the course of 2021 with grace periods depending on the risk class. The guidance document can be found here.
For Northern Ireland, specific provisions apply: For example, manufacturers based outside the UK who want to put a device on the Northern Ireland market must employ a UKRP that has premises in the UK if they do not have a designated authorised representative that has a registered place of business in Northern Ireland. Devices registered with the MHRA for the purposes of Great Britain can be placed on the Northern Ireland market without having to register again in Northern Ireland. Manufacturers and UKRPs can register for the new registration regime with the MHRA database since 1 January, 2021.
The MHRA issued another document on the last day of 2020 giving guidance on regulating medical devices in the UK. It also included information on the new domestic UK database to replace the EU’s NANDO information system.
The guidance advises that UK approved bodies can carry out UKCA mark conformity assessments for medical devices, active implantable medical devices and in vitro diagnostic medical devices for the Great Britain market. However, they cannot perform conformity assessments with respect to the CE marking, except for purposes of the CE UKNI marking which is valid in Northern Ireland.
Several other guidance and updates were also published regarding
- informing the MHRA about a clinical investigation for a medical device,
- EU regulations for the MDR and IVDR (Northern Ireland), and
- an update on the Border Operating Model (how the UK/EU border will operate in the post-transition period.
Source: Medtech Insight (an Informa product)