Included in the Responsible Person service
- Announcement to MHRA that UKMDR is your UK Responsible Person.
- Registration of your medical device(s) with the UK according to the grace period corresponding to the device class.
- Compliance with the obligations stipulated by MHRA:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, 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 device.
- Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
- 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.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Provide a list of your UK commercial representatives to MHRA.
From January 1st 2021, the UK will adopt the UKCA (UK Conformity Assessed) marking system that will be used for certain goods, including medical devices.
CE marked devices will continue to be accepted on the Great Britain market until 30 June 2023, after which all medical devices will be required to have UKCA certification.
The UK government is also setting up a new domestic UK database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
MHRA continues to provide guidance on the implementation and practicalities of the new guidelines and UKMDR can accompany you through this period of transition while coordinating with your UK Approved Notified Body.