UK responsible Person

At the end of the 11-month transition phase, the United Kingdom separated from the EU on January 1, 2021 after years of arduous negotiations. In order to facilitate trade between the EU and the UK, the agreement contains some provisions for the medical technology industry.

Nonetheless, companies face new, additional hurdles as both parties are now viewed as separate areas of law and regulation. In our role as UK Responsible Person, we ensure for our customers, among other things, that their declaration of conformity and technical documentation are available and that the applicable UK MDR 2002 (amendment 2019) requirements have been implemented.

We will keep a copy of these documents and relevant certificates available and will forward them to the UK Medicines Regulatory and Regulatory Authority (MHRA) upon request. In addition, in consultation with the customer, we ensure the use of suitable conformity assessment procedures and generally work closely together as a link between the medical device manufacturer and the MHRA on various inquiries.

In order to facilitate our customers’ market access in Great Britain through the service of the UK Responsible Person and to meet the above requirements, MEDAGENT International UK Limited was recently founded.

As a result, MEDAGENT can now fully assume the role of UK Responsible Person. Contact us to find out more about MEDAGENT’s service and the UK medical device registration process.

When do which products have to be registered on the MHRA database?

  • active implantable medical devices
  • Riskclass III
  • Riskclass IIb (implantable)
  • IVD List A
  • Riskclass IIb (not implantable)
  • Riskclass IIa
  • IVD List B
  • Riskclass I
  • custom made devices
  • general IVD
  • sytsem and process packages

As a UK Responsible Person, we can help you continue to gain free market access in the UK within these time limits with minimal effort.

In just three steps we will register you in the UK via the MHRA database.

Step 1:  Receive templates

In the first step, you will receive ready-made templates from us. These contain information about your company and the medical devices you wish to register in the UK. We can register up to 100 product groups (grouped by GMDN codes) per registration with a maximum of 20,000 items via the MHRA database. The cost of the registration in the UK is £100 per registration. In addition, under the UK MDR 2002, technical documentations must be provided to your UK Responsible Person if this is required by the UK authority. We first check the status of your technical documentation regarding up-to-dateness and completeness, we will gladly give you a feedback on this and support you in closing any gaps if necessary.

Step 2:  Fill in templates

While you fill in the templates sent to you, we will check your files. Throughout the registration process, you can contact us any time and we gladly help to clarify any questions you may have about how best to prepare your registration information. Once all the templates have been completed, your work is done. After returning the completed templates and checking the received information, the registration on the MHRA database will begin.

Step 3: We register you in the UK

From this step on, you are almost completely detached from the process as a manufacturer. We will submit all information via the MHRA database and will be in contact with the english authority for you. After successful submission, we will receive a feedback from the english authority in the shortest possible time. Thus, with us you are officially registered in the UK within three steps and can continue to market your products smoothly and safely.

If you have any further questions about UK registration or the function of the UK Responsible Person, please feel free to contact us using the contact form below!

Contact UK Responsible Person

MEDAGENT INTERNATIONAL UK LIMITED
Meridian House
Bluebell Business Estate
Sheffield Park
East Sussex, TN22 3HQ, UK
E-Mail: mail(at)medagent.co.uk