UK MHRA MEDICAL DEVICE REGISTRATION

Before being sold in the United Kingdom, all medical devices, IVDs, and custom-made devices must be registered with the MHRA so-called MHRA Registration. This is mandatory for all types of devices. To be registered with the MHRA in the United Kingdom (England, Wales, and Scotland), devices must comply with the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023).

Where the manufacturer or their UK Responsible Person has a registered place of business in the UK, the MHRA device registration is feasible. If the manufacturer is located outside of the United Kingdom, they must nominate a UK Responsible Person with a registered business address in the United Kingdom.

MHRA DEVICE REGISTRATION PROCESS

The following are the states for UK MHRA registration

  • Appoint UK Responsible person if the manufacturer is located outside UK

  • Apply with MHRA by submitting declaration of Conformity and UKRP Agreement

  • Submit additional documents from technical file if asked by MHRA

  • Receive Registration details

UK FREE SALE CERTIFICATE (FSC)

Certificates of Free Sale (CFS) should not be construed as an endorsement by the government of any product mentioned on the certificate.

MHRA will issue a separate CFS according to on the manufacturer, UK Responsible Person, or Authorized Representative’s location, and the mark of conformity.

Export of Medical Device from UK

Export of Medical Device from Non regulated marked to other non-regulated markets

The following can apply Certificate of Free Sale

  • UK-based manufacturer,
  • UK Responsible Person or
  • Northern Ireland-based Authorised Representative.

The following can apply Certificate of Free Sale

  • UK-based manufacturer,
  • UK Responsible Person or
  • Northern Ireland-based Authorised Representative.

Certificate of Free Sale is valid for the life of the item or set of devices for which it was issued.

Notarization, also known as a notarial act, is the process of giving legal proof that the Certificate of Free Sale (CFS) owner has attested to the document’s authenticity and reliability. Usually, non-European regulatory authorities ask for it.

BEST PRICE OFFER

I3CGLOBAL is one of the leading regulatory consulting organizations having multiple offices across the world. We have the experience and technical know-how about the device(s). We are not just a UKRP service provider!!

  • 24X6 Chat support

  • 6 days working and processing files

  • Economic pricing and polite staff

Class I: £950

Class A and Class Is / r/ m: £1050

Class B and Class IIa: £1200

Class C and Class IIb: £1300

Class D and Class III: £1400

Note: Each additional device / GMDN will incur fee of £100.

We ONLY provide this service to NON-UK and IRELAND manufacturers.

Class A and Class I : £650 per device / GMDN Code

Class B and Class Is / Im /Ir : £700 per device / GMDN Code

Class C and Class IIa, IIb: £750 per device / GMDN Code

Class D and Class III: £800 per device / GMDN Code

* MHRA Fees included. 

Important: To begin the procedure, overseas manufacturers must use our UKRP service and complete MHRA medical device registration.

Application Processing: £2000 ( Upto 2 devices and additional devices £500 extra)

Service Fee: £1500

Notarization: £250

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