UK Responsible Person and EU Authorised Representative

SOLUTIONS

If you are an EU manufacturer looking to gain access to the device market in Great Britain, or are a U.K manufacturer looking to sell your devices into Europe, our team are here to help! 

Due to our unique position and being based in Northern Ireland, we can we can act as both your U.K Responsible Person AND your European Authorised Representative.

 

Our services include: 

▪  Regulatory pre-compliance check for the UK market

▪  Device registration for the UK market

▪  Retention of a UK Responsible Person and regulatory experts to act on behalf of your company in the UK 

▪  Informing the manufacturer of any complaints and vigilance reports received in the UK

▪  Corresponding with the UK regulatory authority as required

▪  Document retention and provision to the UK’s MHRA as required

UK Responsible Person

The regulation defined by the MHRA states the only lawful way for non-UK manufacturers to sell their devices into the UK is through the use of a UK responsible person. 

The UK rep must be established in the UK and act on behalf of the manufacturer to perform specific tasks, such as the registration of medical devices at the regulatory authority before they are placed on the UK market.

20200514PHT79112-ml.jpg

EU Authorised Representative

 

We are also able to act as your EU Authorised Representative in Europe due to the Northern Ireland Protocol agreed between the UK and Europe.

Our services include: 

▪  Regulatory pre-compliance check for the EU against the requirements of the EU MDR 

▪  Verification of manufacturer documentation and retention of documents in accordance with the MDR requirements

▪  Verification of registration obligations for all parties

▪  Device registration for the EU market

▪  Retention of a European Authorised Representative and a Person Responsible for Regulatory Compliance to act on behalf of your company in the EU

▪  Informing the manufacturer of any complaints and vigilance reports received in the EU

▪  Cooperation as required with regulatory authorities on your behalf

Do you need support?  Book in your free no obligation consultation 

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

Social

  • LinkedIn
  • Facebook

Copyright © 2020 Meddev Solutions Ltd. All rights reserved.          Privacy Policy