Brexit officially happened on January 1, 2021. What was for some a reason for celebration is the source of additional hassle for others, including medical device manufacturers.
It is important for medical device manufacturers to understand what regulatory requirements they have to comply with and what transitional periods they will benefit from if they want to continue selling their devices in the UK.
The transitional period during which EU law was still applicable in the UK ended on December 31, 2020. UK law has applied since January 1, but it is still based on old EU law:
For medical devices, the UK Medical Devices Regulations 2002 apply. And these continue to reference the (old) EU directives, for example, the:
For manufacturers who have just switched to the MDR, this means having to rollback. The good news, however, is that the requirements of the MDR are more or less the superset of the requirements established in the EU directives.
With the EU directives, the requirements for conformity assessment procedures and CE marking also continue to be applicable in the UK.
The United Kingdom will recognize medical device manufacturers’ CE marking until June 30, 2023. Declarations of conformity according to the old EU directives as well as the MDR and IVDR will be recognized. In other words, manufacturers do not have to go through an additional conformity assessment procedure during this period.
After June 30, 2023, manufacturers will also have to carry out a conformity assessment procedure, but this will not result in a CE mark but with a UKCA (UK Conformity Assessed Mark).
To get this UKCA, manufacturers will have go through a UK approved body, which is the equivalent to a notified body, because the UK conformity assessment procedure is still based on the EU directives. At least until the UK passes other regulations.
It is not currently clear whether the UK will pass a new regulatory framework in time for July 1, 2023. The foundation for a fundamental overhaul of the current law was put in place with the passing of the Medicines and Medical Devices Bill in February 2021.
However, the United Kingdom is still not free to change or even increase these requirements however it wants. The “Brexit Deal” sets limits for these requirements because you only allow the largely free movement of goods if neither side uses regulations to close off their market.
Because the UK requirements are equivalent to the EU directives, manufacturers do not need to involve a UK approved body in the conformity assessment procedures for class I devices.
However, manufacturers importing products into the UK must register with the UK’s health regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
There are transitional periods, which are given below, for this registration.
It is not the manufacturer who has to register but the “UK responsible person”. You can find more information about this below.
Read more about registering medical devices on the MHRA’s web site.
EU manufacturers who want to market their medical devices in the UK must do the following by June 30, 2023:
The transitional periods for the registration of devices depend on the device type and class:
Device type and class
– Class III devices
– Implantable class IIb devices
– All active implantable devices
– List A IVDs
May 1, 2021
– Other class IIb devices
– All class IIa devices
– List B IVDs
– IVDs for self-testing
September 1, 2021
– Class I, customized and other IVDs
January 1, 2022
By the end of 2021, all medical devices sold in the UK must be registered there.
As mentioned above, there is a transitional period for the conformity assessment procedures:
Brexit has made it mandatory to have a UK responsible person. This person must be resident in the UK and be registered with the MHRA. This person is comparable to the authorized representatives according to the MDR and IVDR (German) and has to carry out the following activities:
If the Responsible Person suspects that the manufacturer is not fulfilling its legal obligations, they must end their legal relationship with the manufacturer and inform the MHRA and, if applicable, the relevant approved body.
Importers must inform the UK responsible person of their activities. They can also take on this role. Distributors have no additional obligations to fulfill.
After June 30, 2023, all medical device manufacturers who want to place their devices on the market in the UK will have work with a UK approved body, at least if their devices are in classes I*, IIa, IIb or III.
According to the UK government’s web site, there are currently only three accredited companies: SGS, BSI and UL.
Because the regulatory requirements for medical devices placed on the market in the UK continue to be based on the EU directives, there are no different or additional essential requirements.
However, the MHRA has started to share its thoughts on “human factors engineering”, which are much more closely aligned with the FDA’s requirements than those of IEC 62366. On the other hand, manufacturers who follow IEC 62366-1 are also likely to meet the MHRA’s usability requirements.
No changes are being planned initially for labeling, including the symbols, either. However, from July 1, 2023, the CE marking must be replaced by the UKCA mark.
As the old directives did not require a UDI, this requirement does not apply in the UK. Of course, there is nothing wrong with manufacturers placing devices on the market in the UK with a UDI.
The MHRA’s requirements for the QM system do not differ from the corresponding requirements in the EU. ISO 13485:2016 and/or the requirements of, e.g., Annex II of the MDD are authoritative here as well.
In contrast, the vigilance requirements have always differed between individual countries, e.g., in terms of the format, the deadlines, and the recipients of vigilance reports.
The MHRA gives guidance on vigilance and other information on its website. The agency continues to rely on the MEDDEV guidelines, specifically MEDDEV 2.12/1 (German).
Either the manufacturer or the UK Responsible Person is responsible for the notifications.
The situation is particularly complicated for devices that are to be marketed in Northern Ireland. EU law, not UK law, applies for these devices. In other words, the MDR and IVDR will apply in Northern Ireland from May 26, 2021 and May 26, 2022 respectively!
Therefore, based on the current situation in Northern Ireland, the obligation to have CE marking will remain in effect after June 30, 2023. However, a UK responsible person, who, among other things, is responsible for registering the devices in the MHRA’s database, is still required.
There is an exemption from the requirement for a UK responsible person for class I devices, customized devices and other IVDs that have already been registered in the EU.
Another special regulation concerns labeling: if a UK approved body is involved in the conformity assessment, then a UKNI mark is required in addition to the CE mark. However, the combination of both markings is intended for the Northern Irish market only and is mandatory in this case. Within the EU, only the CE mark may be used. Additional use of the UKNI mark when placing a device on the market in, for example, Germany is not permitted.
Read more on the special arrangements for Northern Ireland in a PDF from the UK government and on the UKNI marking here.
For UK manufacturers who want to place devices on the market in the EU, European regulations, such as the MDR, apply. This means they will need to find an EU notified body from January 1, 2021 onwards. Devices placed on the market in the EU before January 1, 2021 can still be made available and put into operation there.
If UK manufacturers want to market their devices in Northern Ireland, they will need an EC rep or authorized representative based in Northern Ireland.
In the world of medical device manufacturers at least, there are no winners from Brexit. There are (almost) only losers.
Assuming that the MDR and IVDR fulfill their promise to increase the safety, performance and benefit of medical devices, British patients will lose out since, in Britain, devices will only have to comply with the “old” requirements of the EU directives.
Placing devices on the market becomes more difficult for EU manufacturers.
All this additional expense has to be paid for – by the UK healthcare system. Or manufacturers could decide to stop marketing their devices in the UK. And then the UK healthcare system no longer has access to them.
For EU manufacturers, this rollback to the EU directives means the additional effort just described for the registration, the additional conformity assessment procedure and the addition of the UK approved body.
Whether it’s the customs authorities, the MHRA or the European authorities responsible for market surveillance: they all have to go through additional bureaucracy that does not lead to any additional safety. On the contrary: redundant or additional and unnecessary tasks keep the authorities from doing their real duty. A duty that is already obviously more than challenging.
“Take back control” was one of the slogans of Brexit supporters. The result is that the UK is now working with outdated regulations. The fact that these are EU regulations seems like a bad joke.
Good medical devices are good medical devices. Therefore, the aim should be to create uniform regulations worldwide. Brexit was unfortunately a step in the other direction. What a shame.