In the year 2019, on September 18th UK MHRA released new guidance regarding the role and responsibilities of the “UK Responsible Person (UKRP)” to regulate medical devices sold in the United Kingdom after a no-deal Brexit. The concept is very similar to European Authorized Representative for Medical Devices and its role for devices sold in the EU. If an enterprise sets itself up as a UK Responsible Person for Medical Devices, the Person would have responsibility for the entire enterprise.
UK Responsible Person For Medical Devices
UK Responsible Person Roles & Responsibilities
- UKRP ensure that the declaration of conformity and the technical documents have been established and that, where possible, the manufacturer has conducted an appropriate conformity evaluation procedure.
- Keep a copy of the technical documentation, a copy of the declaration of conformity, and, if applicable, a copy of the relevant certificate for inspection by the MHRA.
- In response to a request from the MHRA, provide the MHRA with all information and documentation required to demonstrate a device’s conformity.
- Forward any MHRA request for samples or access to a device to the manufacturer, and ensure that the MHRA receives the samples or access the device.
- Jointly work with the MHRA to eliminate or, when not possible, reduce the risk posed by devices in any preventive or corrective action.
- Inform the manufacturer as soon as possible about complaints and reports from healthcare professionals, patients, and users about suspected incidents involving a device for which they have been designated.
- If the manufacturer fails to comply with these Regulations, terminate the legal relationship with the manufacturer and notify the MHRA and, if applicable, the relevant certification body.
UK MHRA Registration of Medical and IVD Devices
- Manufacturer Name & Address as per device labeling
- Company Type
- Manufacturer contact information
- Mutual signed Agreement between Manufacturer and UK Responsible Persons
- 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.
Our Pricing For UKRP Services
|Class I||Class Is||Class IIa||Class IIb||Class III|
|950 GBP||1050 GBP||1150 GBP||1250 GBP||1450 GBP|
INVITRO DIAGNOSTIC DEVICES
|Class A||Class B||Class C||Class D|
|1100 GBP||1200 GBP||1300 GBP||1400 GBP|
Class A / GMDN Code
Class B / GMDN Code
Class C / GMDN Code
Class D / GMDN Code
|650 GBP||700 GBP||750 GBP||800 GBP|
|MHRA Fees included. ( Applicable for Non-UK Legal manufacturers)|
MHRA Registration Requirements and Timeline
Domestic and International Manufacturers and Importers wishing to place a device on the Great Britain market need to register with the MHRA. This is applicable for medical devices and in-vitro diagnostic devices of all classes. Only if the manufacturer or their UK Representative has a registered place of business in the UK is registration possible.
Following information’s to be provided at the time of MHRA Registration
|May 1, 2021|
|September 1, 2021|
|January 1, 2022|
If the devices are not registered by the above dates, they will not be able to be sold lawfully in the United Kingdom.
Furthermore, you might be interested to export Class 1 devices or Notified Body CE Certified Medical Devices to the UK. Write to us for more information.
Who all are UK approved bodies for UKCA Mark Certifications?
Presently 3 approved bodies, but gradually it may increased to 10 by end of 2022.
Is the present MHRA policy covers EU Regulations? If yes which all regulations covers?
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).