UK Responsible Person Services

UK Rep Med, your UK Responsible Person

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!

Scroll for information as to why UK Rep Med is your best option.

UK Rep Med is here to help so please dont hesitate to contact us with any questions

Which Responsible Person ?

Does your Responsible person:

• Focus in medical devices ?
• Have experience of medical devices UK market?
• Have UK medical device regulatory and commercial experience ?
• Have in-depth knowledge of UK, NHS, Private Healthcare and MHRA?
• Provide you with up to date changes of UK CA Medical Devices requirements ?

UK RepMed Limited or your UK Distributor?

Use an independent UK responsible person to maximise opportunities:

• Are your technical files confidential?
• Will you ever need to switch distributors?
• Will you want more than one distributor?
• Is Brand image important?

If you answer any of these questions 'yes' then you need an independent UK Responsible Person and UK Rep Med Limited's services

Shall I use my UK Distributor ?

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

Responsibilities

• Keep available a copy of the Technical Documentation
• Verify the Declaration of Conformity
• Review the Technical Documentation
• Review current CE Certification
• Check where applicable that an appropriate conformity assessment exist
• Keep the previous documentation (Declaration of Conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities
• Record Retention and Document control including version controls.
• Ensure Labelling is correct

MHRA Registration

• Ensure registration on all agreed product lines
• Keep documented processes in line with MHRA regulations
• 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
• 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.
• Forward to the manufacturer any request by the MHRA for samples and ensure all processes are completed in respect to any such request from the MHRA

Vigilance Report / Monitoring

• Immediately tell the manufacturer about complaints and reports from MHRA, healthcare professionals, patients and users related to suspected incidents performed by their device.