As of 1 January 2021, Non-UK based manufacturers will become legally obliged to designate a UK Responsible Person to place their devices on the UK market.

As of 1 January 2021, Non-UK based manufacturers will become legally obliged to designate a UK Responsible Person to place their devices on the UK market.

Under the draft UK bill (“The Medicines and Medical Devices Bill 2019-21”) which is currently going through the UK Parliamentary process for ratification, the role of the UK Responsible Person will be decoupled from the role of the UK importer. This means that it is highly recommended to designate a professional agency as the UK Responsible Person.

Under the draft UK bill (“The Medicines and Medical Devices Bill 2019-21”) which is currently going through the UK Parliamentary process for ratification, the role of the UK Responsible Person will be decoupled from the role of the UK importer. This means that it is highly recommended to designate a professional agency as the UK Responsible Person.

Ensure technical documentations have been drawn up

Ensure technical documentations have been drawn up

BREXIT - WHAT YOU SHOULD KNOW

BREXIT - WHAT YOU SHOULD KNOW

Keep a copy of technical documentations for inspection

Keep a copy of technical documentations for inspection

Inform the manufacturer of complaints and incidents 

Inform the manufacturer of complaints and incidents 

Register devices with MHRA

Register devices with MHRA

Cooperate and Provide MHRA all information upon request

Cooperate and Provide MHRA all information upon request

All Right Reserved 2021 © Obelis Group

All Right Reserved 2021 © Obelis Group

Stay in touch

Stay in touch

Need assistance with Cosmetic Products on the UK market?

Need assistance with Cosmetic Products on the UK market?

As your UK Responsible Person, Obelis UK Ltd. will:

As your UK Responsible Person, Obelis UK Ltd. will:

Why should your UK RP be Obelis UK Ltd. 

(under the Obelis Group) ? 

Why should your UK RP be Obelis UK Ltd. 

(under the Obelis Group) ? 

Creating compliance for safer markets is in our roots.  

Managing dedicated Information platform to ensure EU MDR & IVDR compliance as well as UK compliance

At Obelis, we are helping more than 3,000 companies over 70 countries to sell their products on the European market, UK included. 

Creating compliance for safer markets is in our roots.  

Managing dedicated Information platform to ensure EU MDR & IVDR compliance as well as UK compliance

At Obelis, we are helping more than 3,000 companies over 70 countries to sell their products on the European market, UK included. 

We represent the largest center for consultancy in Europe

We represent the largest center for consultancy in Europe

We have more than 30 years of business experience

We have more than 30 years of business experience

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups

Our regulatory expertise is provided by professionals trained by the European Authorities.

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups

Our regulatory expertise is provided by professionals trained by the European Authorities.

We are ISO 9001:2015 and ISO 13485:2016 Certified

We are ISO 9001:2015 and ISO 13485:2016 Certified

Ensuring the highest quality of service for your business.

Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets across the world. 

Ensuring the highest quality of service for your business.

Member of European Association of Authorized Representatives (E.A.A.R.). With a strong international network, Obelis Group supports your business in 18 global markets across the world. 

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Obelis UK Ltd. will be able to register your Medical Devices and IVDs in the UK within 6 working days! 

Obelis UK Ltd. will be able to register your Medical Devices and IVDs in the UK within 6 working days! 

Device Registration in the UK

Device Registration in the UK

UK Labels

UK Labels

UK CA Mark

UK CA Mark

Manufacturers will need to apply changes to their labels when placing them on the GB market. This includes the new UKCA Mark and the UK RP details on the label at the latest when the UKCA mark appears. 

It is important to remember that devices bearing CE mark will not be required  to be relabeled with the UKCA until 1 July 2023. Furthermore, CE marking will be allowed to continue to appear on the label of devices made available on the GB market. This means that devices that bear a dual mark on their label can continue to be sold on the GB market event after the 1st of July 2023 by virtue of carrying the UKCA mark. 

Manufacturers will need to apply changes to their labels when placing them on the GB market. This includes the new UKCA Mark and the UK RP details on the label at the latest when the UKCA mark appears. 

It is important to remember that devices bearing CE mark will not be required  to be relabeled with the UKCA until 1 July 2023. Furthermore, CE marking will be allowed to continue to appear on the label of devices made available on the GB market. This means that devices that bear a dual mark on their label can continue to be sold on the GB market event after the 1st of July 2023 by virtue of carrying the UKCA mark. 

Manufacturers will need to apply changes to their labels when placing them on the UK Market. This includes the new UKCA Marking and to have the UK RP identified on the label at the latest when the UKCA mark appears. 

It is important to remember that the CE marking will be allowed to continue to appear on the label of devices made available on the UK Market. This means that devices that bear a dual mark on their label can continue to be sold on the UK market event after the 1st of July 2023 by virtue of carrying the UKCA mark. 

Manufacturers will need to apply changes to their labels when placing them on the UK Market. This includes the new UKCA Marking and to have the UK RP identified on the label at the latest when the UKCA mark appears. 

It is important to remember that the CE marking will be allowed to continue to appear on the label of devices made available on the UK Market. This means that devices that bear a dual mark on their label can continue to be sold on the UK market event after the 1st of July 2023 by virtue of carrying the UKCA mark. 

From 1 January 2021, all medical devices and in vitro diagnostic medical devices will need to be registered with the MHRA before being placed on the UK market. 

However, the registration of medical devices will be staggered depending on the risk class of the devices: 

Registration by 30 April 2021 for high risk devices: 

- class III, IIb implantable devices and AIM devices & IVD List A

Registration by 31 August 2021 for medium risk devices 

- class IIa and IIb non-implantable medical devices  & IVD List B and Self-testing

Registration by 31 December 2021 for low risk devices

- class I medical devices  & general IVDs

From 1 January 2021, all medical devices and in vitro diagnostic medical devices will need to be registered with the MHRA before being placed on the UK market. 

However, the registration of medical devices will be staggered depending on the risk class of the devices: 

Registration by 30 April 2021 for high risk devices: 

- class III, IIb implantable devices and AIM devices & IVD List A

Registration by 31 August 2021 for medium risk devices 

- class IIa and IIb non-implantable medical devices  & IVD List B and Self-testing

Registration by 31 December 2021 for low risk devices

- class I medical devices  & general IVDs

Represent the manufacturer

Represent the manufacturer

Special rules will apply to devices placed on the NI market:

- EU legislation will need to be followed & CE mark will need to be affixed or

- In case a UK Approved Body performs the conformity assessment, a UKNI marking will be required; 

- The upcoming EU MDR and IVDR will apply as of their application dates;

Appointment of a UK RP as of 1 January 2021 & registration to the MHRA by:

- 1 January 2021: Class I devices, custom-made devices and general IVDs 

- 1 May 2021: Class III and Class IIb implantables, AIM and IVD List A

- 1 September 2021: Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs

Special rules will apply to devices placed on the NI market:

- EU legislation will need to be followed & CE mark will need to be affixed or

- In case a UK Approved Body performs the conformity assessment, a UKNI marking will be required; 

- The upcoming EU MDR and IVDR will apply as of their application dates;

Appointment of a UK RP as of 1 January 2021 & registration to the MHRA by:

- 1 January 2021: Class I devices, custom-made devices and general IVDs 

- 1 May 2021: Class III and Class IIb implantables, AIM and IVD List A

- 1 September 2021: Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs

CN

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