1. Which enterprises need to pay attention to the UKCA requirements

1) If you have medical device products to be sold to the UK market;2) If you have medical device products to be sold to the EU (except the UK), but your previous European Authorized Representative is in the UK.

2. If your medical device products are to be sold to the UK market, your solutions include:

2.1 In the case of NI market

1) Continue implementing the CE certification according to the MDR and IVDR requirements;

2) Affix the CE mark;

3) Designate an European Authorized Representative or a UK Responsible Person;

4) Complete the MHRA registration of products;

5) Put the products on the market for sale.

2.2 In the case of GB market

1) UKCA can be applied from January 1, 2021; UKCA must be applied from July 1, 2023;

2) Affix the UKCA mark;

3) Designate a UK Responsible Person;

4) Complete the MHRA registration of products;

5) Put the products on the market for sale.

3. Who can perform the UKCA/CE certification

1) CE certification: It must be implemented by a notified body authorized by the EU. The original notified body in the UK cannot perform the CE certification.

2) UKCA certification: It must be implemented by a UK certification body authorized. The original notified body in the UK will be automatically converted into a UKCA certification body.

4. Who is responsible for the MHRA registration

1) The MHRA is responsible for the review and approval of registration;

2) The manufacturers in the UK and Northern Ireland can declare the MHRA registration on their own.

3) In other regions in the world, the registration shall be declared via the UK Responsible Person (a legal person or natural person located in the UK).