If a medical device or IVD manufacturer sells, leases, lends or gives away a device on the UK market, the UK MDR 2002 requires you to notify the MHRA (Medicines and healthcare products regulatory agency) before placing the device on the UK market. UK. If the manufacturer is located outside the UK, they must appoint a UK responsible person with a place of business in the UK, or a UK agent (UK agent for short). The tasks of the UKCA mark approval body will vary depending on the classification of the relevant product and the conformity assessment route chosen by the manufacturer. The conformity assessment procedure will be based on the Annex defined in the Medical Devices Regulations 2002.
Class I, IIa, IIb or III devices that you manufacture; Class I, IIa, IIb or III devices that you refurbish or relabel with your own name; Any system or package that contains at least one medical device; Custom-made devices; In vitro diagnostic devices IVDs that you manufacture.
Manufacturer details;
The name and address of the legal entity as it appears on the device label/packaging;
Company type, e.g. limited company, sole trader;
Administrative contact (there can be up to 15 people with access rights);
Letter of appointment from the UK responsible person (or UK representative contract). This must be a legal contract stating that you are the only UK responsible person acting on behalf of the manufacturer and specifying the mandatory tasks you undertake on behalf of the manufacturer. The mandatory tasks that must appear in the appointment contract can be found in our regulatory guidance for UK responsible persons;
Self-declaration of conformity for the device.
Which regulations apply;
The class of device you are registering;
The Global Medical Device Nomenclature (GMDN) code and terminology used to describe your device;
Basic UDI-DI (if applicable);
Medical device name (brand/trade/proprietary name);
Model or version details;
Catalogue/reference number;
UDI-DI (if applicable);
UK approved body (or EU notified body) (if applicable);
Attributes such as sterile, containing latex, MRI compatible;
You will also need to provide a copy of any conformity assessment certificate or self-certified declaration of conformity (if applicable).
Apply to register on the Device Online Registration System (DORS); Use the website to fill in the details and create an MHRA account request; You will receive a confirmation that the account request has been accepted or rejected; Once registered, your company name and address will be added to the Public Access Registration Database (PARD: https://pard.mhra.gov.uk). The MHRA registration database contains the manufacturer’s name, address, and MHRA reference (account) number.
MHRA registration must be renewed one year after you submit your registration application or confirmation, and every two years after this date. If your registration renewal fails, your record will be deleted from the MHRA database. You will then need to apply for a new registration, otherwise you will no longer be able to place your device on the UK market.
