The EU Medical Device Regulation (Regulation 2017/745) (EU MDR) and In Vitro Diagnostics Regulation (Regulation 2017/746) (EU IVDR) require the sponsors of clinical investigations and certain performance studies to be established in the EU (or Northern Ireland) or have a legal representative established in the EU (or Northern Ireland).
The performance studies in scope of this requirement are any:
- In which surgically invasive sample-taking is done only for the purpose of the performance study;
- That is an interventional clinical performance study as defined in point (46) of Article 2 of the EU IVDR;
- Where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; or
- That involves companion diagnostics, excluding those involving companion diagnostics using only left-over samples.
The EU regulations allow Member States and the UK in respect of Northern Ireland, to disapply this requirement if the investigation or study is only taking place in their territory and nowhere else in the EU.
The MHRA is disapplying the requirement for the sponsor or their legal representative of a clinical investigation or performance study to be established in the EU or Northern Ireland, provided all of the following conditions are met:
- The investigation or study must also be taking place in both Northern Ireland and Great Britain.
- The investigation or study must not be taking place in an EU Member State.
- The sponsor must be either established in or have a written agreement with a legal representative in Great Britain, who is responsible for ensuring compliance with the sponsor’s obligations in the EU MDR or EU IVDR.
- The sponsor must establish a contact person in Northern Ireland for the clinical investigation or performance study, who will be the addressee for all communications with the sponsor provided for in EU MDR or EU IVDR. Any communication with that contact person is deemed to be communication with the sponsor.
- Where the sponsor is established in Great Britain, they must have a written agreement with the contact person. The agreement must provide for the contact person to immediately inform the sponsor of all communications received as the sponsor’s contact person. The sponsor must agree to share with the contact person all information necessary to enable the contact person to manage the sponsor’s communications.
- Where there is a legal representative in Great Britain, they must have written agreements with the sponsor and with the contact person in Northern Ireland.
- The agreement with the sponsor must provide for the legal representative to be responsible for ensuring compliance with the sponsor’s obligations in the EU MDR or EU IVDR. The legal representative must agree to immediately inform the sponsor of all communications received as the sponsor’s legal representative. In turn, the sponsor must agree to share with its legal representative all information necessary to enable the legal representative to carry out its duties.
- The agreement with the contact person must provide for the contact person to immediately inform the legal representative of all communications received as the sponsor’s contact person. The legal representative must agree to share with the contact person all information necessary to enable the contact person to manage the sponsor’s communications.
- Sponsors that consider their proposed clinical investigation or performance study meets the above conditions, must include the name, address and contact details of their contact person in Northern Ireland and if there is one, their legal representative in Great Britain, in the application form and clinical investigation plan/clinical performance study plan.
All remaining requirements under the EU MDR and EU IVDR apply. This guidance will take immediate effect.
The temporary disapplication of Sponsors & Legal Representatives in NI is now published by MHRA:
The 2 links where made the same updates are:
Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
Information about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland
Notify the MHRA about a clinical investigation for a medical device
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.