The Medicines & Healthcare products Regulatory Agency (MHRA) has been responsible for medical device and pharmaceutical regulations in the United Kingdom since 2003. It merged with the National Institute for Biological Standards and Control (NIBSC) in 2013, and so it now covers three main regulatory areas:
- Clinical Practice Research Datalink – sells anonymized health care data to pharmaceutical companies, academics and other regulators for research.
- MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries.
- National Institute for Biological Standards and Control – responsible for standardizing and controlling biological medicines.
How does the UK categorize medical devices?
Medical devices are categorized in the UK based on the level of risk associated with them, similar to how countries in the European Union categorize medical devices.
If your product is established as a general medical device, it will fall into one of four categories:
- Class I – low risk
- Class IIa – medium risk
- Class IIb – medium risk
- Class III – high risk
The MHRA decides which category the medical device will be placed in based on several factors, including:
- the intended purpose of the device
- how long the device is intended to be used for
- whether the device is invasive/surgically invasive
- whether the device is implantable or active
- whether the device contains a substance considered to be a medical substance in its own right
All active implantable medical devices (and their accessories) fall into Class III (highest risk).
In Vitro Diagnostic (IVD) medical devices are categorized differently, as follows:
- general IVD medical devices
- within the classification stated in Part IV of the UK MDR 2002, Annex II List A (as modified by Part III of Schedule 2A to the UK MDR 2002)
- within the classification stated in Part IV of the UK MDR 2002, Annex II List B (as modified by Part III of Schedule 2A to the UK MDR 2002)
- for self-test (intended to be used by a person at home)
Medical device product registration
If you want to market your medical device in the UK, then the device must have valid CE marking. Without it, you cannot place your device on the European Union market.
CE marking signifies that your product meets all relevant European medical device regulations’ General Safety and Performance Requirements (GSPR). CE marking is valid for five years, regardless of which country it has been issued in.
If the medical device manufacturer doesn’t operate within the EU, they must appoint an Authorized Representative.
The length of time it takes for a medical device to be registered will vary depending on the device’s classification.
How has Brexit affected the EU Medical Device Regulation?
The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) have replaced the old European Union Medical Device Directives.
The MHRA will continue to recognize existing CE marking and EU certificates until June 20, 2023. After this date, medical devices will require a UK Conformity Assessed (UKCA) mark.
However, the EU will not recognize the UKCA mark, so a CE mark will still be required for medical devices sold in EU markets.
Medical devices sold in Northern Ireland will require both CE and UKCA marks.
Therefore, medical device manufacturers based outside of the UK selling medical devices in the UK will be required to appoint a UK Person Responsible (UKPR).
Shiro Business Solutions provide specialist advice and assistance to MedTech and Medical Device companies operating in the EU and international markets, helping them to meet regulatory requirements while maintaining commercial control.