UK Responsible Person
UK Responsible Person (UKRP)
On September 18th, 2019, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued updated advice on the role and duties of the “UK Representative” in regulating medical devices marketed in the UK during a no-deal Brexit. The notion is quite similar to the job of the European Authorized Representative for Medical Devices in the EU. If a company establishes itself as a UK Responsible Person (UKRP) for Medical Devices, the UKRP is responsible for the whole company.
Role Of UK Responsible Person For Medical Device
- Ascertain that the declaration of conformity and technical papers have been prepared, and that the manufacturer has performed an adequate conformity evaluation method, if possible.
- For inspection by the MHRA, keep a copy of the technical documentation, a copy of the declaration of compliance, and, if appropriate, a copy of the relevant certificate.
- Provide all information and documentation necessary by the MHRA to show a device’s compliance in response to a request from the MHRA.
- Any MHRA request for samples or access to a device should be forwarded to the manufacturer, and the manufacturer should guarantee that the samples or access are received by the MHRA.
- In any preventative or corrective action, collaborate with the MHRA to remove or, if that is not feasible, limit the risk presented by devices.
- Notify the manufacturer as quickly as possible about any complaints or reports of suspected occurrences involving a device for which they have been designated.
- Terminate the legal connection with the manufacturer and inform the MHRA and, if appropriate, the relevant certifying authority if the manufacturer fails to comply with these Regulations.
UK MHRA Registration Of Medical And IVD Devices
(A) Manufacturer Information
- According to the device labelling, the manufacturer’s name and address are:
- Type of Business
- Contact information for the manufacturer
- Manufacturer and UK Responsible Persons have reached a mutual agreement.
(B) Device Information
- Applicable Regulation
- Device Risk Class
- Global Medical Devices Nomenclature (GMDN) code
- Basic UDI-DI (if applicable)
- Device Name, Brand,
- Device model or Variants with product Code / Catalogue number
- UK Approved Body (or EU Notified Body) Certificate for all device above risk class I
- Nature of Sterility / contains latex/ Phthalate /MRI compatible etc.
MHRA Registration Requirements And Timeline
Domestic and international manufacturers and importers who want to sell a device in the United Kingdom must first register with the Medicines and Healthcare Products Regulatory Agency (MHRA). This applies to all kinds of medical equipment including in-vitro diagnostic gadgets. Registration is only feasible if the manufacturer or their UK Representative has a registered place of business in the UK.
Following information’s to be provided at the time of MHRA Registration
|May 1, 2021|
- Active implantable medical devices
- Class III medical devices,
- Class IIb implantable medical devices and
- IVD List A devices
|September 1, 2021|
|January 1, 2022|
If the gadgets are not registered by these dates, they will not be able to be sold lawfully in the United Kingdom.
Presently 3 approved bodies, but gradually it may increased to 10 by end of 2022.
Medical Devices Directive (MDD),
Active Implantable Medical Devices Directive (AIMDD),
In Vitro Diagnostic Medical Devices Directive (IVDD),
Medical Devices Regulation 2017/745 (MDR),
In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).