Brexit

Since the results of the referendum held on June 23, 2016 decided that the people of the United Kingdom would prefer to leave the European Union, the term “Brexit” has become standard terminology. The British (BR) people want to leave (EXIT) the EU. However, the exact implications were unclear for a long time. There has been a long discussion to decide whether UK would prefer a soft Brexit, with minimal political and business implications, or a hard Brexit, where they will clearly differentiate themselves from the other countries. 

In the meantime, it became clear that UK currently leans towards a hard Brexit. As for all other sectors, also IVD and MD industry are affected. Manufacturers should definitely start preparing if they intend to continue their business in the United Kingdom after 2020.

Impact on IVD and MD industry

The UK government will probably decide to go for a hard Brexit, meaning the UK becomes a third country. This has serious consequences on the IVD and MD industry: 

  • UK manufacturers will need an Authorized Representative to legally place their devices on the EU market;
  • Third country manufacturers with a UK based Authorized Representative will need to transfer to another Authorized Representative which is still located in an EU member state; 
  • New local UK registration requirements will have to be implemented.

The new regulations that amend the UK’s Medical Device Regulation laid down by UK parliament at the beginning of 2019 introduced the concept of a “UK Responsible Person”. 
Similar to the European idea of an Authorized Representative, the UK Responsible Person would act on behalf of a manufacturer established outside the UK.

E.g. The UK responsible person must ensure that the declaration of conformity and technical documentation have been drawn up. He shall also cooperate with the Secretary of State on any preventive or corrective actions regarding to the products and inform the manufacturer about complaints and reports about suspected incidents related to a device for which they have been designated.

As expert company in the field of IVD and Medical devices, Qarad decided to open a new office based in the UK to provide an answer to the worldwide concerns regarding Brexit in their field. 

 

Dr. Dirk Stynen, General Manager of Qarad: 
Since the official opening of Qarad UK Ltd., Qarad is now able to help all IVD and MD manufacturers around the world. Our companies in Belgium and the Netherlands can provide all non-EU manufacturers, including the ones from UK, with the Authorized Representative services as defined in the different European regulations and directives. And thanks to our new office in the UK, we will also be able to assist the non-UK manufacturers to continue their businesses in the UK by acting as UK responsible person.”

 

Contact us for more information!

What does this mean for you?

 

Contact us for more information about our EC REP and UK REP services

*
*
*
*

QARAD BV

ISO Certified
ISO 13485 and ISO 27001

Quicklinks

Website by Contents by Qarad Terms and conditions  Privacy policy  Cookie policy 
Close

Attention!

This website uses cookies to enhance your surfing experience.
Certain webfunctions rely on the usage of these cookies.
If you want more information regarding our cookie policy, you may visit this link.