MHRA Authorised Representative Services

 

The LKW Medical Group can act as an MHRA Authorised Representative.

 

LKW Medical Group can act as an MHRA UK Authorised Representative for your medical products sold in the UK.

 

If you have products that require registration with the MHRA, use the contact form above and we will get in touch with you. 

Dates and points to be aware of:

The regulation for Medical Devices (MDR), will regulate certain groups of products without an intended medical purpose, listed under Annex XVI, as medical devices.  Dermal Filler a specific example included in Annex XVI in Group 3. This means that, by 26th May 2020, in line with all other medical devices, will be required to comply with the obligations set out in the MDR.

 

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.  From 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering: Class 3 MDD must be registered from 1 May 2021.

The UKCA marking will apply to most goods currently subject to the CE marking. It will also apply to aerosol products.  From 1 January 2021 the technical requirements (‘essential requirements’) you must meet – and the conformity assessment processes and standards that can be used to demonstrate conformity – will be largely the same as they are now.  The UKCA marking can be used from 1 January 2021.

 

If your products are manufactured outside the UK and you wish to place a device on the UK market, you will need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.  Manufacturers should aim to appoint their UK Responsible Persons as soon as possible. The UK Responsible Person will then need to register relevant devices with the MHRA in line with the above grace periods depending on the device class.

In Principle LKW Medical can undertake a number of your responsibilities in respect to the MHRA which include but are not limited to:

  • Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.

  • Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.

  • In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.

  • Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.

  • Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.

  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.