Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU
On 1st September, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published its latest Guidance outlining the requirements for placing medical devices on the markets of Great Britain (England, Scotland and Wales), Northern Ireland (NIR) and the European Union (EU) respectively.
The guidance provides some insight into how certain aspects of the UK’s system will operate, including:
- Getting devices certified;
- Conformity marking of devices;
- Registering devices with the MHRA.
Regarding the MHRA itself, starting on 1st January, 2021, it will take on the responsibilities that are currently undertaken via the EU system, and become the principal entity for the medical devices market in the UK. Moreover, the MHRA will continue to perform market surveillance for medical devices on the UK market and will be able to take decisions over the marketing and supply of devices in the UK. The MHRA will also retain responsibility over the designation and monitoring of UK Conformity Assessment Bodies (UK approved bodies).
Before we delve into the specifics of this guidance, it is important to emphasise that this document is not legally binding and the proposals therein do not, as it stands, have the force of law. For the proposals in this guidance to take effect, certain legislative changes, which are foreseen for later in 2020, will first have to be introduced. This makes the guidance subject to parliamentary approval.
In terms of the legislation, at the time of writing, medical devices in Great Britain are regulated under:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD);
- Directive 93/42/EEC on medical devices (EU MDD);
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD).
These directives are transposed and given effect into UK law via the Medical Devices Regulations 2002 (SI 2002 No.618, as amended) (UK MDR 2002). These transposing regulations, as they appear on 1st January, 2021 will continue to have effect in Great Britain after the end of the transition period.
As for the incoming EU Regulations on Medical Devices (MDR) and on In-vitro Diagnostic Devices (IVDR), these will fully apply to EU Member States as of 21st May 2021 and 2022, respectively. This means that these Regulations will not take effect until after the transition period and, as such, they will not be within the scope of the EU Withdrawal Agreement Act that will retain EU law, and will not automatically apply to Great Britain at the end of the transition period.
Requirements for entities manufacturing and supplying devices in Great Britain
Starting from the 1st of January 2021, when the transition period ends, there will be a number of changes that will affect how medical devices are regulated on the Market in/of Great Britain. Some of the changes and novelties of the upcoming regime are:
- CE marking will continue to be accepted until 30th June, 2023;
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30th June, 2023;
- Starting from 1st January, 2021 a new system for marking (UKCA) and placing devices on the market will be available for manufacturers wishing to place a device on the Great Britain market. Where applicable, mandatory, third-party interventions in this system will be carried out by UK approved bodies;
- Starting from 1st January, 2021, all medical devices and in-vitro diagnostic medical devices (IVDs) already placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices;
- 8 months for other Class IIb and all Class IIa devices;
- 12 months for Class I devices.
- The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA anyway;
- After 1st January, 2021, Manufacturers who are established outside of the UK and wish to place a device on the UK market will need to appoint a UK Responsible Person who will take responsibility for the product in the UK.
In the following section, we will elaborate on the upcoming changes and novelties of the new system, summarised above.
As of 1st January, 2021, manufacturers wishing to place a device on the UK market will first have to register with the MHRA. Where a manufacturer is not established in the UK, it will need to designate a UK Responsible Person (UK RP) to register with the MHRA and act on its behalf. A UK RP must, by definition, have a registered place of business in the UK.
Moreover, from 1st January, 2021, all medical devices, including IVD and custom-made, must be registered with the MHRA before they can be placed on the Great Britain market. The MHRA will only register devices for registered manufacturers who are established in the UK, or for registered UK RPs who will have assumed the responsibilities of non-GB-based manufacturers. The registration of a manufacturer, or their UK RP, with the MHRA can therefore be seen as a pre-requisite for the registration of specific devices.
The aforementioned registration requirements will not apply before 1st January, 2021, and depending on the class and type of device, a grace period will be granted for the registrations to be completed under the new process. The same grace period also applies to the requirement to appoint a UK RP. This means that in cases where a UK RP is required, the appointment of the UK RP and its subsequent device registration must both be completed before the end of the grace period for that particular type/class of device. The grace periods are as follows, starting from 1st January, 2021:
For the following devices, the grace period is 4 months to register with the MHRA (until 30th April, 2021):
- Active implantable medical devices;
- Class III medical devices;
- Class IIb implantable medical devices;
- IVD List A.
For the following devices, the grade period is 8 months to register with the MHRA (until 31st August 2021):
- Class IIb non-implantable medical devices;
- Class IIa medical devices;
- IVD List B;
- Self-test IVDs.
For the following devices, the grade period is 12 months to register with the MHRA (until 31st December 2021):
- Class I medical devices;
- General IVDs
- The 12-month grace period will not apply to manufacturers of Class I medical devices and general IVDs who are currently required to register with the MHRA. More specifically, this includes manufacturers who are based in the UK or who have a UK-based authorised representative and must register with the MHRA at present anyway.
The grace period for the registration of custom-made devices will be determined according to their risk classification. Failure to register by these dates means that manufacturers will no longer be able to lawfully place their device on the UK market.
Duties of the UK Responsible Person
The UK RP must be established in the UK and will act on behalf of the non-UK based manufacturer who has appointed it and carry out specific tasks in relation to the manufacturer’s obligation. Such tasks for the UK RP include, as already touched upon, registering with the MHRA before the manufacturer’s devices can be placed on the market. The exact responsibilities of the UK RP will be set out in detail by the UK MDR 2002, as it will appear on 1st January, 2021. In summary, however, the UK RP must:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- Keep available 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 for inspection by the MHRA;
- 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;
- Forward to the manufacturer any of the MHRA’s requests for samples or access to a device, and ensure that the MHRA receives the samples or has been given access to the device;
- 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 have been designated;
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
Transitioning form, the CE mark and NBs to, the UKCA mark and UK approved bodies
The UKCA (UK conformity assessed) mark is the newly introduced UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market. Manufacturers of devices that will be placed on the Great Britain market will be able to use this mark starting from the end of the transition period, i.e. 1st January, 2021. The MHRA will continue to recognise the CE mark until 1st July, 2023 for devices placed on the Great Britain market that have been CE marked under and, fully conform with, any of the current Directives or incoming Regulations of the EU for Medical Devices (Active implantable medical devices) and IVD devices.
The UKCA mark will not, however, be recognised in the EU, EEA and NIR markets and as such it will not be interchangeable with the CE mark outside of Great Britain. To this effect, devices that will be placed on those markets will continue to need a CE mark for this purpose. From 1st July, 2023, the UKCA will be the only marking recognised in Great Britain and as such all manufacturers will need to meet the relevant requirements and place the UKCA mark on their devices.
Starting from 1st January, 2021, the MHRA will be able to designate “UK Approved Bodies” to conduct conformity assessments against relevant requirements for affixing the UKCA mark. UK notified bodies (NB) which are currently designated under the MDD, IVDD or AIMDD will have their designations automatically recognised under the new regime and will become UK approved bodies without having to undergo a re-designation process.
The UK approved bodies will only be able to conduct conformity assessments in relation to the UKCA mark (as opposed to the CE mark), for medical devices, active implantable medical devices and in-vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 (as it will appear on 1st January, 2021).
In the same vein as the CE marking system, manufactures of Class I medical devices and general IVDs can self-declare the conformity of their devices on the basis of Part II and Part IV of the UK MDR 2002, before affixing the UKCA mark. Manufacturers who are currently CE marking their devices, on the basis on self-certification, can continue to do so after 1st January, 2021 and place their devices on the Great Britain market in this way until 30th June, 2023. Moreover, Class I devices that are sold sterile (Is) or have a measuring function (Im) will still require approval from an Approved Body in order to have the UKCA mark affixed on them and be placed on the Great Britain market.
With regard to devices that require NB intervention; certificates issued by EEA-based NB will continue to be valid for placing devices on the Great Britain market until 30th June, 2023, or until the certificate’s expiry, whichever date comes first. Opting for the CE mark path to place devices on the Great Britain market requires that any third-party, mandatory intervention and certification will have to be carried out by an EEA-based NB. This will permit the affixing of the CE mark on the device, which, as already seen, will allow for it to be placed on both the EU and UK markets. This is in contrast to the UKCA mark path, which requires the intervention and certification to be carried out by a UK approved body and is only valid for placing a device on the Great Britain market. However, even with the temporarily universal CE mark affixed on the device, the manufacturer will still need to designate an EEA, EU or NIR-based representative for those markets, and a separate UK RP for the Great Britain market.
Lastly, from 1st January, 2021, under the UK MDR 2002, a CE marked device with a valid declaration of conformity or certificate will be viewed as meeting the UKCA mark requirements whilst the CE mark continues to be recognised in Great Britain. This will include devices placed on the market that conform with the EU MDR or EU IVDR.
Therefore, any enforcement or market surveillance powers available in respect of the UKCA mark will apply to CE-marked devices. For certificates that have been issued by a UK Notified Body, the Body will be automatically designated as a UK Approved Body and will continue to oversee these devices and their manufacturers to ensure continued compliance with the applicable standards of safety and performance under the UKCA mark.
Devices placed on the Great Britain market after 1st January, 2021 may either carry the CE mark or the UKCA mark, depending on which legislation has been used as the basis for the conformity assessment and certification of the device. The number of the NB or UK approved body will also have to appear on the label, where applicable.
Devices that will carry a valid CE mark, at the end of the transition period, will not be required to be re-labeled with the UKCA until 1st July, 2023. During this time, they may be placed on the Great Britain market with the CE mark on their label. Devices that carry a dual mark on their label can continue to be sold on the Great Britain market after 1st July, 2023 by virtue of carrying the UKCA mark, irrespective of the CE mark also appearing on the label.
Northern Ireland market
The market of Northern Ireland (NI) will be regulated differently than the market of Great Britain, however the registration of devices with the MHRA will be needed and the MHRA will remain the competent authority for the NI market.
The need for appointing UK Responsible Person/E.A.R. and who and which devices shall be registered with the MHRA will depend on the location of the manufacturer. For ex. the MHRA Guidance requires from a non-EU manufacturer to designate a UK Responsible Person, who must register Class I device, Class IIa device, Class IIb device, Class III device, Annex II List A IVD, Annex II List B IVD or self-test IVD before placing it on the NI market.
Furthermore, the EU legislation will need to be followed, and CE mark will need to be affixed before placing a product on the NI market. Moreover, the upcoming EU MDR and IVDR will apply in the Northern Ireland.
Important to note that the UK Approved Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market and the "UK(NI) mark will accompany, but not replace, the CE mark. UKCA marked devices will not be accepted on the Northern Ireland market unless accompanied by the CE or CE UK(NI) mark".
Placing a device on the EU Market
CE marking devices destined for the EU market after the transition period
Starting on 1st January, 2021, devices for the EU market will have to continue adhering to the applicable EU legislation and be affixed with the CE mark to demonstrate compliance. If a UK based NB (UK approved body) is used for a conformity assessment of a device, then the following will apply:
- In accordance with the Withdrawal Agreement, devices assessed by UK NBs and placed on the EU market prior to 1st January, 2021, may remain on the market;
- From 1st January, 2021, however, devices for which any mandatory, third-party conformity assessment has been carried out by the UK NB or approved body, will not be able to be placed on the EU market. An EEA-based NB will be required for this purpose.
The results of any mandatory, third-party conformity assessment that has been carried out by a UK NB/approved body will not be recognised by the EU, even if the assessment took place prior to the end of the transition period. The only exception is for cases where the assessment has been concluded and the device has already been placed on the EU market, prior to 1st January, 2021. In short, the UK NB’s assessment of the device and the placing on the EU market of the device must both occur before the transition period is over. A timely assessment by a UK NB is irrelevant if the placement on the EU market is after 1st January, 2021. For devices to be placed on the EU market after 31st December, 2020, the conformity assessment must be carried out by an EEA-based NB.
Manufacturers who CE mark their devices on the basis of a self-declaration, for the purpose of placing them on the EU market, can continue to do so after the end of the transition period. The only difference is that these manufacturers will need to appoint an EU or NIR-based authorised representative, if their current one is based in the UK.
Certain UK-based NBs are already, at the time of writing, taking the necessary measures so that manufactures can continue to export to the EU without having to find a new EU NB. Manufacturers whose UK NB is not taking such measures must either get their devices assessed by an EU-recognised NB, or arrange for the files of their devices to be transferred to an EU-recognised NB prior to 1st January, 2021.
Great Britain-based authorised representatives will not be recognised in the EU after the end of the transition period, even if the devices for which they are designated were placed on the EU market before 1st January, 2021. As such, Great Britain-based authorised representatives (or UK RPs) will not be able to carry out tasks on the manufacturers’ behalf for the purpose of placing devices on the EU market.
To this effect, manufacturers who are based outside of the EU and whose current authorised representative is based in Great Britain, must engage a different authorised representative for the EU market. This authorised representative must be based in the EU or NIR. Likewise, manufactures based in Great Britain, who wish to continue supplying CE-marked devices to the EU market, must also appoint a different, EU or NIR-based authorised representative, for this purpose.
Manufacturers who will place devices on the EU market, after 1st January, 2021, must ensure that their devices comply with the labelling requirements of the EU.
Thus, the UKCA cannot appear on the products marketed on the EU territory.
Manufacturers will need to ensure different labelling for products shipped to the Great Britain and products shipped to the EU
Obelis will continue to monitor developments as this Guidance progresses through the Parliament and becomes UK law.
The changes that will be introduced in the medical devices regulation in the UK will impact non-Great Britain-based and Great Britain-based manufacturers who seek to place devices on the Great Britain market, alike. The impact will also extend to manufacturers who wish to continue placing devices on the EU market, but are currently with a UK-based EAR and/or notified body.
Are you a manufacturer of medical devices and find yourself in one of the groups impacted by these changes? Are you unsure as to what the impact on your business will be?
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Reference: Guidance - Regulating medical devices from 1 January 2021: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021?utm_source=3cb979f4-5c7e-44fb-aebb-05b8426c0f7a&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate