UK Responsible person responsibilities of the UK Medical Device Market

Currently, the UK participates in the European regulatory network for medical devices, but once the transition period is over, this participation will also end. But what will remain the same and what will change? 

The answers to these questions are below.

  • All devices that comply with the applicable EU Directive will continue to be allowed until June 2023
  • Changes to the labeling of the affected products will not be required. Labels in English that include information from other jurisdictions will be accepted.
  •  The product can still carry a CE mark and devices that require conformity assessment by a notified body must have a valid CE certificate.
  • On the day of departure, a UK regulatory system will be available. All the key elements that are included in the EU regulations will appear in it.
  •  MDR and IVDR will not be "active" in the UK, but both regulations will be accepted until the end of June 2023.
  •  A change in the role of notified bodies will be implemented

As of January 1, 2021, all medical devices marketed in the UK must have one of the acceptable markings: the CE mark or the new UKCA. 

The type of mark will only depend on the legislation under which the device has been certified. If the operator of the medical device (manufacturer) already has a valid CE mark on the devices, they will not need to be re-labeled until 1 July 2023 for them to be placed on the market in Great Britain.

 

As of 1 January 2021, the 'Name' and 'Address' information of the UK Responsible Person must be included on the product label where the UKCA mark has been affixed.

 

As of 1 January 2021, before being marketed in the UK, medical devices of all classes must be registered with the MHRA. UK manufacturers must register and manufacturers outside the UK must designate a responsible person. For new registrations only, a grace period will apply.

 

If the medical device is already registered with the MHRA, it will not be necessary to re-register. However, medical device manufacturers will need to review the information held by the MHRA.

Why Choose I3CGLOBAL for UK Responsible Person for Medical Device Registration?

We are medical device regulatory consultants and representatives for several nations and regulations. We can provide a UK Responsible Person & UKRP Person Service through our UK office. Since 1999, we’ve been providing a variety of services to medical device manufacturers all around the world. All of our clients are guaranteed to be successful.

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