From the 1st January 2022 all Manufacturers based outside the UK need to appoint a UK Responsible Person who then registers the devices with the UK competent health authority (MHRA). This needs to be done to import medical devices into the UK.
This is a requirement under the new UK MDR set out by the MHRA.Click here for more detail
UK Rep Med can act as your responsible person!
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UK Rep Med is here to help so please dont hesitate to contact us with any questions
Does your Responsible person:
Use an independent UK responsible person to maximise opportunities:
If you answer any of these questions 'yes' then you need an independent UK Responsible Person and UK Rep Med Limited's services
The benefit of using UK Rep Med Limited instead of your distributor is that you maintain control of how your products are marketed in the UK . Using a distributor seems the simplest option but you may into major problems if you answered yes to any of the above questions.
Each of these points are crucial not only in terms of working together but protecting your UK business UK Responsible person-UK MDR-UK Authorised representative
Vigilance Report / Monitoring