HDA UK Media and Political Bulletin – 15 April 2021
PharmiWeb, PharmiWeb Editor, 14 April 2021
This whitepaper by PharmiWeb summarises Medicines and Healthcare products Regulatory Agency (MHRA) guidance on the regulation of medical devices after Brexit. Covering existing legislation, the role of manufacturers and UK-based Responsible Persons, conformity assessments, the placement of products on the UK market, and post-market surveillance, the paper provides a clear list of actions for manufacturers in order to prevent delays and/or blocks to placing products on the UK market. The paper also details the specific regulatory rules for medical devices in Northern Ireland and the European Union respectively.
There was no parliamentary coverage today.
PharmiWeb, PharmiWeb Editor, 14 April 2021
From January 1, 2021, the transition period after Brexit ended, and the Medicines and Healthcare products Regulatory Agency (MHRA) took on the role as the UK’s standalone medicines and medical devices regulator.
On 1 September 2020, the MHRA published a set of guidance on what the rules will be from 1 January 2021. The guidance on medical devices have been subsequently updated on October 21, November 4 and December 31.
This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance and vigilance that will apply for devices placed on the market in Great Britain (England, Wales and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.
Key elements of the MHRA’s guideline
Legislation in Great Britain
Currently, EU Directives for Active Implantable Medicals Devices (AIMDD), Medical Devices (MDD), and In-Vitro Diagnostic Devices (IVDD) have been enacted in UK law, through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), referred to as ‘UK MDR 2002’ hereafter. The UK MDR 2002 will continue to apply in the UK after January 2021, but it will be amended to include changes required for the new UK status.
Because the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) will only fully apply from May 26, 2021 and May 26, 2022 respectively, they will not automatically apply in Great Britain. An independent safety committee recognized the importance of strengthening the current UK regulation in the interest of patient safety. They will consider international standards and global harmonization in the development of the future regulatory system and consult stakeholders from the industry and healthcare sector on the proposed system.
In order to place a device on the UK market, the manufacturer will first need to register with the MHRA. Previously, only medical device manufacturers based in the UK or those that had a UK- based Authorised Representative (AR) were required to register with MHRA. Where a manufacturer is not established in the UK, it must designate a UK Responsible Person (UK RP), to register and act on its behalf.
Before registering a device and placing it on the market, the manufacturer will need to comply with the UK legislation relevant to its products.
UK Responsible Person
In order to place a device on the Great Britain Market, non-UK manufacturers will be required to designate a UK Responsible Person, physically based in the UK. The UK RP will act on the behalf of the manufacturer to carry out specific tasks. The responsibilities of the UK RP are similar to those of the EU Authorised Representative under the Directives. The UK RP must ensure that the Declaration of Conformity and the technical documentation have been drawn up and the conformity assessment performed correctly. They are required to keep a copy of the technical documentation and the Declaration of Conformity of the device available for MHRA inspection. They will be the MHRA point of contact regarding requests for information, samples or any preventive or corrective actions to mitigate risks posed by the device. They will need to inform the manufacturer about complaints and incident reports they are aware of. If the manufacturer acts contrary to its obligations, the UK RP must terminate the contract and inform the MHRA and the relevant Notified Body. The UK RP will register the devices and will provide a list of importers to the MHRA.
Manufacturers should appoint a UK RP as soon as possible.
From January 1, 2021, the UK introduced a new product marking that will be used for certain goods including medical devices being placed on the Great Britain market: The UKCA (UK Conformity Assessed). It is voluntary from January 1, 2021 and mandatory for medical devices from July 1, 2023.
MHRA will designate UK Approved Bodies to conduct assessments against the relevant requirements (of UK MDR 2002 for medical devices). Existing UK Notified Bodies with designation under MDD, IVDD and AIMDD will be automatically designated as Approved Bodies under UK MDR 2002. These Bodies are: BSI UK (MDD, IVDD and AIMDD), SGS UK (MDD and IVDD) and UL international UK (IVDD). The UK Approved Bodies will be published in a new UK database.
Similar to class I devices in the EU, manufacturers of Class I devices and general IVDs will be able to self-certify conformity to UK MDR 2002 before affixing a UKCA mark on their device. Devices that are sterile or with a measuring function will need assessment by an Approved Body.
Until June 30, 2023, the MHRA will continue to authorize CE-marked devices to be placed on the Great Britain market. This applies to self-certified devices and to devices with certificates issued by EEA-based Notified Bodies under the MDD, AIMDD, IVDD, MDR and IVDR.
If devices have a certificate issued only by a UK Notified Body, the re-designation as a UK Approved Body means that the conformity will be recognized under the UKCA mark, rather than the CE mark.
Other economic operators
From January 2021, placement of medical devices from the EU on the UK market will be considered as ‘importing’. The current obligations of the importers according to the current UK MDR 2002, includes but are not limited to: ensuring the product is safe; warning patients and users about the potential risks of using the device; monitoring the safety of devices and taking appropriate actions if any safety issues occur. The importer will need to inform the UK RP of their intention to import a device into the UK. Further requirements for importers and distributors may be introduced in the revised UK MDR 2002 (to align with the EU MDR requirements), but they have not been discussed in the latest guidance.
Placement of products on the UK market
From January 1, 2021, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the Great Britain market. This will need to be done by the UK manufacturer or the UK RP if the manufacturer is outside of the UK. As registration cannot start before January 1, 2021, a grace period is allowed for the registrations to be completed; higher risk devices such as Class III, active implantable, Class IIb implantable devices and IVD List A have a grace period of 4 months (they must be registered from May 1, 2021). The remaining Class II devices, IVD List B and self-test IVDs have 8 months (from September 1, 2021) and Class I devices and general IVDs have 12 months to register with MHRA (from January 1, 2022). It will be possible to register devices ahead of the above dates for all classes. Each application will be subject to a fee (£100 per application).
From January 2021, medical devices placed on the Great Britain market will need to have either a CE mark or a UKCA mark, with the number of the Notified Body /Approved Body if relevant on their label. However, if the device has a valid CE mark, there is no need to re-label the device with a UKCA mark until July 1, 2023. Dual-labelling (CE and UKCA marks) will be accepted in Great Britain after July 1, 2023. If a product is placed on the market with a UKCA mark, the name and address of the UK RP must be included on the label. There is no need to include the importer’s name and address on the label.
Post-market surveillance and vigilance
The requirements for the manufacturers to report certain incidents to MHRA will not change. They must also continue to take appropriate safety action and submit and corrective actions to the MHRA when required.
The requirements for clinical investigations will not change. The UK will continue to recognize existing clinical investigation approvals, both for regulatory and ethics approvals and so, there will be no need to re-apply. The Sponsor of a trial should be established in the UK or they will require a UK-based legal representative. UK clinical investigation applications will continue to be authorized by MHRA and Ethics Committees as they are at present. To start any new clinical investigations, MHRA must be informed at least 60 days prior to commencing the study.
Regulation of medical devices in Northern Ireland
The rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain.
Devices will still need to comply to EU regulations and be CE marked before they can be placed on the Northern Ireland market. It means that if a Notified Body assessment is required, it will have to be done by an EEA-based Notified Body. The EU MDR and IVR will apply in Northern Ireland from May 26, 2021 and May 26, 2022 respectively.
If the product is intended only for the Northern Ireland market, UK Approved Bodies will be able to carry out an assessment and the device will need to bear a CE UKNI mark that allows the product to be marketed only in Northern Ireland.
As for Great Britain, medical devices will need to be registered with MHRA before being placed on the Northern Ireland market. The grace period for registration is the same as the one described for Great Britain. The responsibilities for this registration depend on the location of the manufacturer and device classes:
– A manufacturer located in Northern Ireland will register all devices with MHRA themselves;
– A manufacturer located in Great Britain will need to designate an EU Authorised Representative. If the AR is in Northern Ireland, they will register all devices with MHRA. If the AR is in another EEA country, they will only need to register Class IIa, IIb, III devices and List A, B and self-test IVDs with the MHRA. The other classes of devices will be registered in the EU member state where the EU AR is located.
– A manufacturer located in the EEA will need to designate a UK RP to register all devices except class I medical devices, custom made and general IVDs, which have been registered with an EU Competent Authority.
– A manufacturer located outside of the UK and EEA will need to designate a UK RP to register the devices unless their AR is based in Northern Ireland. In this case, the AR will register the devices with MHRA.
When devices are registered with MHRA for the purpose of Northern Ireland, they do not need further registration for Great Britain.
Any conformity mark held by a NI business that validates the sale on the NI market will be valid for the whole UK market. Devices that are marked CE or CE UKNI by a NI manufacturer will be allowed on the Great Britain market after June 30, 2023.
The person importing devices in Northern Ireland will need to inform the NI-based Authorised Representative or the UK Responsible Person.
Regarding post-marketing activities, incidents occurring in Northern Ireland will need to be reported to the MHRA.
Placing Medical Devices on the EU market
From January 1, 2021, EC certificates issued by UK-based Notified Bodies are not recognized in the EU, unless the product was placed on the EU market before the end of 2020.
In order to be able to continue marketing devices in the EU, manufacturers with UK-based Notified Bodies needed to get their devices re-assessed by an EEA-based Notified-Body or arrange for the files to be transferred to an EEA-based Notified Body before January 1, 2021.
UK manufacturers of self-certified devices can still market these devices after January 1, 2021, but they will need to designate an EEA (or Northern Ireland) based Authorised Representative.
Manufacturers based outside the EU who currently have a Great Britain-based Authorised Representative or Great Britain-based manufacturer should have designated an Authorised Representative based in the EEA or Northern Ireland by January 1, 2021 to be able to continue placing devices on the EU market. EU ARs based in Great Britain will no longer be able to operate as EU AR after Brexit.
The guidelines published by the MHRA indicate that all economic operators, particularly the manufacturers, must take action in order to continue the placement of their medical device products on the UK and EU markets. If no actions have been taken until now, manufacturers are likely to experience delays and inability to market their products, until all appropriate requirements are met. Therefore, we recommend that you ensure relevant steps are taken to meet these new requirements. Here we have summarised some of the key actions that must be taken:
- If you are a manufacturer not based in the UK, you must designate a UK RP to market your device in the UK.
- Plan registration with MHRA for the devices marketed in the UK according to MHRA timeline (i.e. 4, 8 or 12 months).
- If you have a UK-based NB, you are required to transfer to an EEA-based NB (independent or entity of your UK-based NB) to continue marketing the device in the EU. Ensure your products’ labeling are updated appropriately.
- A new route to market and product marking will be available from January 1, 2021, and mandatory from July 1, 2023 to place devices on the Great Britain market: The UKCA.
- CE marking and CE certificates issued by EEA-based NB will be valid until June 30, 2023.
- Further information can be requested via email@example.com
Guidance – Regulating medical devices from January 1, 2021. https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021. Published 1 September 2020, revised October 21, November 4, 2020, and December 31.
The Medical Device Regulation 2002- 002 No. 618 Consumer Protection; June 13, 2002 [http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf]
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