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 can be an individual or a company established 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.
Medical Devices (all classes) including Active implantable medical devices and In Vitro Diagnostic Devices.
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.
Yes, if your product holds an UKCA mark and the manufacturer is not located in the UK, you will need to include the details of a UK Responsible Person on the label.
There is no mandatory requirement, but the MHRA expects you to process the PMS activities and manufacturer responsibilities. So, the understanding is, an organization should have a basic QMS system.
Yes, the CE marked products are valid to be placed on the UK market until June 30, 2024 and would require a UK Responsible Person.
The MHRA website provides all the details of a UK Responsible Person and the responsibilities of a UK Responsible Person are detailed in the SI-MDR 2002, as amended.
It is a folder with 10 separate documents required to set up the UK Distributor/Importer/manufacturer as a UK Responsible Person.
The UK Responsible Person Services are made available from Jan 1, 2021.
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.
You can change your UK Responsible Person at any given point of time and a UK Responsible Person would notify the MHRA about termination of services.
Yes, Distributors/Importers can act as a UK Responsible Person.
A UK responsible person’s details are required only for an UKCA label.
Yes, foreign companies can have different UK Responsible Person for different products.
Yes, the product should be UKCA marked if you want to continue marketing the product in Great Britain.
Yes. The MHRA would accept the CE certificate issued under European Regulation (EU) 2017/745.
You can cross-verify it from the MHRA device database. https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200
Yes. The devices will not be allowed for importation into the UK market.
You can inform the MHRA and request some additional time for registration with a justification of why the timelines couldn’t be met.
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.
Yes, it is necessary that UK Responsible Person is based in the UK and have a registered office in the UK.
Yes, if your medical device product has a CE mark issued by the EU Notified Body accredited under the EU MDR regulations, you can place it in the Northern Ireland market.
The MHRA has released transition guidelines for different product categories. You may have to refer to those guidelines to understand the Regulatory requirements.
The manufacturer can appoint only one UK Responsible Person for each brand of a particular device.
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.
MDSAP is not a mandatory requirement by the UK MHRA. The UK MDR 2002 requires the Quality Management Systems to comply with ISO 13485.
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 Responsible Person details have to be included for the products with UKCA Marking.
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.
The manufacturers catering to both the EU and the UK markets may have multiple marking included in single label.
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.
