Medicines Healthcare Products Regulatory Agency
Overview
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to act as the Competent Authority for medical devices in Northern Ireland. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating medical devices.
This guidance is only relevant for medical devices on the Northern Ireland market. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, please see our published guidance.
The legislation
Currently, devices are regulated under:
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
These directives are given effect in UK law through the?Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002). Schedule 1 of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 sets out the specific requirements for Northern Ireland.
The application of the MDR and IVDR in Northern Ireland
The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively.
Under the terms of the?Northern Ireland Protocol, from 1 January 2021, the rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain (England, Wales and Scotland).
The MDR will apply in Northern Ireland from 26 May 2021, and the IVDR will apply in Northern Ireland from 26 May 2022, in line with the EUs implementation timeline.
We recommend you familiarise yourself with the legislation that is applicable to your devices:
- General medical devices:?The Regulation on Medical Devices 2017/745
- In vitro diagnostic medical devices (IVDs):?The Regulation on In Vitro Diagnostic Medical Devices 2017/746
How to comply with the legal requirements
If you are manufacturing or supplying a medical device, you must meet new obligations set out in the Regulations, including, but not limited to, ensuring that:
- the device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
- general safety and performance requirements are met, including for labelling, and technical documentation and quality management systems (Annex I of the MDR and IVDR)
- increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
- manufacturers have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
- as an importer you meet the requirements set out in Article 13 of the MDR and IVDR
- as a distributor you meet the requirements set out in Article 14 of the MDR and IVDR
Introductory guide to MDR and IVDR
We have created an interactive guide to the
Please note that since publication of the above guide the implementation timeline of the MDR has been delayed and will now fully apply from 26 May 2021 in Northern Ireland.
Conformity Assessment marking
For medical devices and IVDs, CE marking will continue to be used and recognised for the Northern Ireland market, and manufacturers based in Northern Ireland will not require an authorised representative established in the EU. For the purposes of the CE mark, an EU-recognised Notified Body, where required, must be used.
Where a UK Notified Body has been used for your conformity assessment, you must place a CE UKNI mark on the device. Goods bearing the CE UKNI marking will not be accepted on the EU market. Further guidance on applying the UKNI marking.
Class I manufacturers can continue to self-declare their conformity against the MDR from 26 May 2021.
Health Institutions in Northern Ireland
Guidance on the health institution exemption (HIE) IVDR and MDR (Northern Ireland)
The exemption for manufacturing or modifying and using medical devices or IVDs within the same health institution (also known as in house manufacture) will continue to apply. However, additional requirements for these devices must be met.
Health institutions wishing to apply the exemption under the new Regulations will need to ensure that:
- products meet the relevant General Safety and Performance Requirements (Annex I of the MDR and IVDR)
- there is an appropriate quality system in place
- there is a justification for applying the exemption
- technical documentation is in place
The full requirements of implementing the healthcare institution exemption can be found in Article 5(5) of the MDR and IVDR.
The MHRA has published guidance on implementing the Health Institution Exemption in Northern Ireland. Please see our detailed guidance document for health institutions in Northern Ireland wishing to apply the exemption to their medical devices or IVDs.