UK Responsible person service from January 2021
From the 1st January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that is currently undertaken through the European Medicines Agency (EMA) . The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking, known as ‘new approach’ goods. However, CE marking will continue to be used and recognised until 30 June 2023, to allow businesses time to adjust to the new requirements until 1 January 2023 in most cases.
Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person must then register relevant devices with the MHRA in line with the grace periods depending on the device class.
NPZ Technology Ltd had worked as the EU authorised representative for the overseas manufacturers before Brexit and had a resourceful experience of working with the UK Health infrastructure, including DIT, NHS supply Chain tenders, Department of Health and Social Care, Test and Trace, MHRA, Public Health England and UKAS accredited Lab in the UK for validation or clinical trial of medical device required by regulatory or notified body (NB).
As the UK Responsible Person, NPZ will:
- Ensure that the Client has put in place an appropriate declaration of conformity along with the correct technical documentation for their product and, where applicable, that an appropriate conformity assessment procedure has been applied;
- Register the Client’s devices with the MHRA;
- Keep available a copy of the Client’s technical documentation, a copy of the declaration of conformity and, if applicable, a copy of relevant certification, including any amendments and supplements for inspection by the MHRA;
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a Client’s device;
- Respond to requests from the MHRA and forward any MHRA requests for samples or access to a device to the Client ensuring that the MHRA requests are fulfilled;
- Cooperate with the MHRA on any preventive or corrective action (CAPA) taken to eliminate or, if that is not possible, mitigate the risks posed by Client’s devices;
- Immediately inform the Client about complaints and reports from healthcare professionals, patients and users about suspected incidents related to one of their devices;
- Terminate the legal relationship with the Client in the unlikely event that they act contrary to their obligations under the applicable Regulations and inform the MHRA and, if applicable, the relevant Notified Body of that termination.
（see more information from www.gov.uk ）
Medica 2021 Exibition
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