The United Kingdom left the European Union on the final day of December 2020, this was before the Medical Device Regulations EU 2017/745, and In vitro Device Regulations EU 2017/746 became fully enforceable, which happened in May 2021 (after a 1-year deferral due to the COVID-19 pandemic). As a result, the UK still follows the three Medical Device Directives for General Medical Devices 93/42/EEC, Active Implantable Devices 90/385/EEC, and 98/79/EC for in vitro diagnostics. These three medical device directives are, incorporated within UK national law under the UK Medical Device Regulations 2002.
Secondary legislation went ahead in 2020 in the form of the Medical Device (EU Exit) Regulations 2020: where provisions had to address new UK requirements.
Medical Device Registration
One of the new requirements is that all existing (not just new) medical devices are now required to be, registered with the UK competent authority, the Medicines and Healthcare products Regulatory Agency (MHRA).
The legislation determines the dates as to when medical devices are required to be registered.
• Class I and custom-made devices, General IVDs, all IVDs undergoing performance evaluation, systems, and procedure packs – 1st January 2021
• Class III and IIb implantable devices, IVD List A products – 1st May 2021
• Class IIa and IIb non-implantable device, IVD List B products, self-test IVDs – 1st September 2021
If you sell and import medical devices into the UK and have still not registered your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA): you must do so as soon as possible. The deadline has now passed for ensuring registration compliance for existing medical devices on the market.
Appointment of a UK Responsible Person
If a medical device manufacturer; is based outside of the United Kingdom and sells or exports their medical devices into the United Kingdom, next they are required to appoint a UK responsible person.
The UK responsible person must:
• Ensure that the declaration of conformity and technical documentation has been drawn up, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
• Keep available for inspection by the MHRA 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;
• 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;
• Where they have samples of the device or access to the device, comply with any request from the MHRA to provide examples or access;
• Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such examples or gain access, and must use communication to the MHRA whether the manufacturer intends to comply with that request;
• 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 are responsible;
• If the manufacturer acts contrary to its obligations under the Regulations—
• Terminate the legal relationship with the manufacturer; and
• Inform the MHRA and, if applicable, the relevant notified body of that termination.
A UK Responsible person must have a registered place of business in the United Kingdom. If you are looking for a UK responsible person, then Patient Guard Limited can provide this service for you.
UKCA Marking
As the UK has left the European Union: the UK can no longer use the CE mark to identify that the medical device is compliant with the regulations. Therefore, the UK has introduced the UKCA mark that replaces the CE mark for medical devices placed in the UK marketplace.
There is a transition period where CE marked products can continue to; be placed onto the UK marketplace until the last day of June 2023. The UKCA mark can be used voluntarily by manufacturers until then. After the final day of June 2023, all medical devices placed onto the UK marketplace will have to display the UKCA mark on all labelling and information provided by the manufacturer.
For Class I devices, the UKCA mark will be via a self-certification process and CE marking. However, for Class Is (Sterile), Class Im (measuring), class IIa, Class IIb and Class III devices, a UK registered notified body will need to issue a certification for UKCA marking. Currently, there are only three UK registered Notified Bodies:
• BSI
• SGS
• UL
There are currently long waiting times for these Notified Bodies even though; there is still over 18 months before UKCA marking is legally required. However, it is integral to factor in that time could be lost whilst waiting for a Notified Body Audit. You should be making provisions now to ensure your technical files comply with the Medical Device Regulations 2002 (as amended) and changing your labeling to include the UKCA mark and UK Responsible Person (if required).
If you need assistance with becoming compliant with UKCA marking, then Patient Guard would be happy to assist you with this.
UK companies selling into Europe
All UK medical Device companies that sell to the European Union whose devices are CE marked are now required to appoint an EU Authorised Representative, as the UK has become a third country.
The Authorised Representative must have a registered business address in one of the member state countries. The Authorised Representative are responsible for registering your devices with the National Competent Authority of the country in which they are based and on the EUDAMED system.
Patient Guard is a registered EU authorised representative in Germany with SRN number DE-AR-000007523 which is within the actor registration portal of the EUDAMED database. If you require an EU Authorised Representative, give us a call or contact Patient Guard to see how we can help you.
The Future of UK Medical Device Regulation?
There has been a public consultation released by the UK Government: on the future regulation of medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) invites the public to provide their views on possible changes to the regulatory framework for medical devices in the United Kingdom (UK). We want to develop a future regime for medical devices which enables:
• Improved patient and public safety.
• Greater transparency of regulatory decision making and medical device information.
• Close alignment with international best practices, and.
• More flexible, responsive, and proportionate regulation of medical devices.
The consultation welcomes the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our future approach to regulating medical devices in the UK.
To share your views on this consultation, complete the online survey here.
The consultation closes on November 25th, 2021.
What about Northern Ireland?
Under the terms of the Northern Ireland Protocol, from the first day of 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 EU’s implementation timeline.
Conformity Assessment marking
For medical devices and IVDs, CE marking will continue to be used and recognised for the Northern Ireland market: manufacturers in Northern Ireland will not require an authorised representative established in the EU. For the CE mark, an EU-recognised Notified Body, where required, must be used.
Wherever 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.
Legal Obligations
If you are an importer, you will need to make sure:
• The device has been CE marked or, for medical devices for the Northern Ireland market only, also has a UKNI indication;
• That the EU declaration of conformity of the device has been composed;
• A manufacturer; is identified and that, where relevant, an authorised representative has been designated by the manufacturer;
• The device is labelled following MDR and accompanied by the required instructions for use;
• Where applicable, a UDI has been assigned by the manufacturer;
• The device has been registered in Eudamed, once Eudamed is fully functional;
• You comply with the manufacturer’s transport and storage requirements;
• You keep a register of complaints of non-conforming devices and recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them;
• You inform the manufacturer and their authorised representative if you have reason to believe a device does not conform to the requirements;
• You keep a copy of the EU declaration of conformity and relevant certificates for ten years (and fifteen years for implantable devices);
• You cooperate with the MHRA and provide samples or grant access to the devices;
Importer obligations are in Article 13 of the MDR and IVDR.
Labeling
Importers will also need to provide the following details along with the device:
• Name registered trade name or registered trademark;
• Your place of business;
• The address at which you can be contacted;
The labelling requirement details can appear on the packaging, instructions for use or in a document accompanying the device, such as an invoice.
Registration Requirements
In cases; where the Northern Ireland importer is not the Northern Ireland-based Authorised Representative or the UK Responsible Person, the importer: is required to inform the relevant Northern Ireland-based Authorised Representative or UK Responsible Person of their intention to import a device. In such cases, the Northern Ireland-based Authorised Representative or UK Responsible Person must provide the MHRA with a list of device importers.
This notification only needs to happen once and not for every batch of devices imported.
The requirements for this go hand-in-hand in line with the registration grace periods.
Where the manufacturer or the Authorised Representative are based; in Northern Ireland, there is no grace period for registering the following devices:
• Class I devices
• Custom-made devices
• General IVDs
• All IVDs undergoing performance evaluation
• Systems and procedure packs
These devices must be registered: with the MHRA presently.
For other device classes, there will be grace periods as follows.
These products must be registered: from 1 May 2021:
• Class III
• Class IIb implantables
• All active implantable medical devices
• IVD List A products
These products must be registered: from 1 September 2021:
• Other Class IIb devices
• All Class IIa devices
• IVD List B products
• Self-test IVDs
If you have already registered your device with the MHRA: for Great Britain (England, Wales and Scotland), it will not need to undergo any further registration in Northern Ireland by the importer, so long as you have indicated that the device is also for the Northern Ireland market. Such devices must meet the regulatory requirements for the Northern Ireland market.
By David Small
