From Jan 1, 2021, non-UK manufacturers have to appoint a UK Responsible Person (United Kingdom Responsible Person) to register their Medical Devices/IVD products with the MHRA and place them in the UK.
A UK Responsible Person shall act on the behalf of a foreign manufacturer and register the devices with the MHRA, before they are placed in the UK market. They shall ensure that the conformity assessment of the device has been completed by the manufacturer and the device technical documentations are available for the MHRA inspection, respond to the MHRA queries (query-response) and carry out Post marketing surveillance & related activities.
The non-UK manufacturer located outside the UK would require a UK Responsible Person to be appointed in the UK for registering their medical devices/IVD products with the MHRA and place them in the UK.
A UK Responsible Person/UK based manufacturer will register the device on behalf of the manufacturer on the MHRA device portal. Freyr is already registered with the MHRA and holds a device registration account.
Yes, in the UK you will need either a CE or an UKCA mark to place the product in the UK. A CE marked product is valid to be placed on the UK market till June 30, 2024 and a UK Responsible Person will need to be appointed, if the manufacturer is not based in the UK.
Service agreement, letter of designation, review of technical documents and registration with the MHRA are some of the critical steps to be followed by a manufacturer to become a UK Responsible Person.
Being your UK Responsible Person, we would verify the technical documents to ensure their compliance to the MHRA regulations. However, the remediation and updating of the technical documentation will not be carried out.
The pathway depends on the markets in scope. In case you target both the EU, and the UK markets you must have a CE mark issued under the EU MDR regulations. You may postpone obtaining the UKCA mark till 2022. In case you target the UK market alone and do not have CE mark issued under the EU MDD or the EU MDR, it is suggested to have UKCA marking for your device. This will vary if you eventually plan to enter the EU market in the future.
The responsibilities and commercials depend on the business contract agreed between your organization and the UK Responsible Person. Importation of devices is not a Regulatory responsibility imposed on UK Responsible Person by the MHRA. In cases where your UK Responsible Person is not acting as an importer, the UK Responsible Person can support with necessary documents and enable the importer to carry out customs clearance activities.
The UK Responsible Person details like name and address are required on the label and the outer packaging and also on the instructions for use for every medical device and IVD which is marketed in the UK.
As a part of the device registration process, the Agreement made between the foreign manufacturer and the UK Responsible Person has to be uploaded in the UK MHRA portal along with the manufacturer details. The Agency reviews this as a part of the device approval process.
It is expected that all the CE certificates issued under the EU MDD will expire by June 2024 and the manufacturers have to apply for conformity assessment for the UK MDR compliance and obtain UKCA marking by then to continue device importation and distribution in the UK. The CE certificates issued under the EU MDR will still be under prevalence and is a mandatory requirement in the European Union. However, these certificates are not accepted by the UK MHRA.
Since it is a new product, we assume that the CE certificate is not in place for the device product in discussion. The grace periods will be applicable to device products that are already placed and actively distributed in the UK market. The new product shall have UKCA mark to place it in the UK market.
The UK MHRA, under the UK MDR 2002, accepts the self-certification for the general IVDs. The manufacturer must have a new declaration of conformity for the UK MHRA compliance. However, the manufacturers shall be vigilant for any revisions in the UK MDR regulations.
The foreign manufacturers may opt to appoint their importers / distributors as their UK Responsible Person. However, it would be ideal to go for a third party UK Responsible Person service provider as their representative in the UK market. Appointing a third-party Agency gives the manufacturer flexibility to appoint multiple distributors and importers to realize their business expansion and market penetration goals. Changing the UK Responsible Person requires your de-registration by old UK Responsible Person followed by re-registration by new UK Responsible Person, pay the registration fees again and change the artworks and labels.
Since the UK MHRA require the UK Responsible Person to maintain a UK MDR compliant technical file, the UK Responsible Person shall have to check whole technical file for compliance. That is one of the reasons why the foreign manufacturers prefer to appoint a third-party Regulatory service provider to act as their UK Responsible Person instead of an importer or distributor.
The CE marked medical device products have to undergo detailed conformity assessment by the UK based conformity assessment bodies to obtain UKCA mark. The device registration made now will not be automatically upgraded as UKCA marked. The UKCA marking which is required for certain medical device products is different from those accepted under the EU MDD/MDR. The manufacturers shall carry out the impact assessment and identify any additional testing requirements for UKCA marking.
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What Our Clients Say
And finally, a big thank you and your entire team for the great effort and the brilliant job. We are very happy to receive the submission acknowledgment from MHRA. Looking forward to more good news from MHRA.
Neurological Diagnostics Manufacturer
Much delighted to receive a positive response from the UK MHRA. Thank you so much and thank you for the good cooperation we had in the last couple of weeks.