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. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

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).

UK Responsible Person | UK Representative

UK Responsible Person (UKRP)

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 UKRP for Medical Devices, the Person would have responsibility for the entire enterprise.

UK Responsible Person Requirements

UK Responsible Person 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

(A) Manufacturer Information

Manufacturer Name & Address as per device labeling
Company Type
Manufacturer contact information
Mutual signed Agreement between Manufacturer and UK Responsible Persons

(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.

UK representative Fee

MEDICAL DEVICE

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

MHRA REGISTRATION



Class I Class A / GMDN Code	Class Is/Im/Ir/IIa Class B / GMDN Code	Class IIb Class C / GMDN Code	Class III 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 UK Representative

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

Active implantable medical devices
Class III medical devices,
Class IIb implantable medical devices and
IVD List A devices

September 1, 2021

Class IIb non-implantable devices,
Class IIa devices,
IVD List B devices,
self-test IVD products

January 1, 2022

Class I medical devices
general IVDs from manufacturers or Authorized Representatives are not based in the UK

UKCA Marking Timeline

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.

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