UK Medical Device Regulation for MDs and IVDs

UKCA 

Brexit implications

Due to Brexit, there will be a new route to market in the UK including new product marking, the UK Conformity assessment mark (UKCA). Manufacturers outside the UK will have to designate a UK Responsible person (UK Rep) to register their devices with the UK Health Authority (MHRA). 

From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. The grace period for registration of medical devices class III and IIb implants as well as list A in vitro diagnostics ended on May 1st 2021. The next deadline for all class IIa, IIb (non-implants), list B in vitro diagnostics and Self-test IVD's was September 1st 2021. Class I devices and General IVDs had a grace period of 12 months. 

The registration with the MHRA can only be submitted by UK manufacturers or UK Responsible Person.

• UK responsible person needs to have a place of business in the UK
• a product list including the products that should be registered as well as the referring GMDN code is required
• If applicable, a copy of the CE certificate should be provided
• documentary evidence supporting the position of the UK Responsible Person is required (letter of designation, signed contract) including company name and address of the manufacturer not located in the UK before June 2023
• One application consists of products having the same GMDN code
• Manufacturers not established in the UK who need to designate a UK Responsible Person do not need to change the labelling of their products placed on the UK market.  

Guidance for the MHRA Brexit by Sue Spencer

Conformity Assessment Body

• From 1 January 2021, the MHRA will be able to designate UK Conformity Assessment Bodies (CABs) to conduct assessments against UK requirements for the purpose of the UKCA mark.
• These Bodies will be known as ‘Approved Bodies’ as of 1 January 2021.
• Existing UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
• UK Approved Bodies will only be able to conduct conformity assessments for medical devices, active implantable medical devices and in vitro diagnostic medical devices under UK MDR 2002 in the form in which they exist on 1 January 2021

The role of the UKRP includes

• Ensure that the Declaration of Conformity (DOC) and technical documentation exist;
• "Keep available a copy" of these documents and relevant certificates; 
• Ensure application of appropriate conformity assessment procedures; and
• Cooperate with the MHRA's request for documents, et al. 

Qserve will offer this service and Qserve’s office in London will be registered with MHRA as a UK Representative with access to the MHRA database for registering manufacturers’ medical devices and IVDs. One of the responsibilities of a UK Rep is accessing the technical documentation and ensuring it is appropriate.

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