UK regulation of medical devices from 1 January 2021. (EU Exit) Regulations 2019 mirror the MDR in UK domestic legislation, with necessary amendments (the UK MDR). The necessary common specifications shall be adopted by 26 May 2020. Under the UK MDR 2002 (as amended), a CE marked device with a valid declaration of conformity or certificate is viewed as meeting the UKCA mark requirements whilst the CE marking will be recognised in Great Britain until 30 June 2023. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest. The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. In addition to the CE marking, device manufacturers also need to apply the UKNI marking if they choose to use a UK Notified Body for mandatory third-party conformity assessment. Check how the new Brexit rules affect you. Once the transition period ends, the UK will no longer be able to update its regulatory schemes for healthcare products and clinical trials through secondary legislation under section 2(2) of the European Communities Act (ECA) or via section 11 of the Consumer Protection Act (CPA) for certain aspects of medical device regulation. Other than the above requirement, there are no additional obligations on distributors or suppliers of medical devices. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system. Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland). Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. By Alina Shrourou, on 9 September 2020. “ “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. In addition, if you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can be placed on the Great Britain market and will not need to undergo any further registration in Great Britain. This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System. On 23 April 2020 the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of … Where incidents occur in Northern Ireland, these need to be reported to the MHRA. you are placing certain medical devices on the Northern Ireland market; and, your goods require mandatory third-party conformity assessment; and. Added a link to our consultation on the Health institution exemption for IVDR/MDR. The following requirements apply to manufacturers wishing to place medical devices on the Northern Ireland market: Unlike Great Britain, the Medical Device Regulations (2017/745) and the in vitro Diagnostic Medical Device Regulations (2017/746) will apply in Northern Ireland from 26 May 2021, and 26 May 2022 respectively, in line with the EU’s implementation timeline. The new regulations have introduced a Unique Device Identification (UDI) System. Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative needs to register all device classes with the MHRA. Devices must be registered in line with the timings set out below. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating medical devices. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods. All content is available under the Open Government Licence v3.0, except where otherwise stated, Medicines and Healthcare products Regulatory Agency, The application of the MDR and IVDR in Northern Ireland, How to comply with the legal requirements, our guidance on regulating medical devices, The Regulation on Medical Devices 2017/745, The Regulation on In Vitro Diagnostic Medical Devices 2017/746, Further guidance on applying the UKNI marking, Guidance on the health institution exemption (HIE) –, Medical devices: software applications (apps), Custom-made medical devices in Great Britain, Medical devices regulations: compliance and enforcement, Medical devices: guidance for manufacturers on vigilance, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, Directive 90/385/EEC on active implantable medical devices (, Directive 98/79/EC on in vitro diagnostic medical devices (, the device has been correctly classified against the new risk classification criteria (Annex VIII of the, general safety and performance requirements are met, including for labelling, and technical documentation and quality management systems (Annex I of the, increased requirements for clinical evidence are met (Annex XIV of the, manufacturers have a person responsible for regulatory compliance in place (Article 15 of the, as an importer you meet the requirements set out in Article 13 of the, as a distributor you meet the requirements set out in Article 14 of the, products meet the relevant General Safety and Performance Requirements (Annex I of the, there is an appropriate quality system in place, there is a justification for applying the exemption. The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. In such cases, the UK Responsible Person is required to provide the MHRA with a list of device importers. “ (6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market. Registration for custom-made devices is in line with the risk class of the device. Registration timings are subject to grace periods and are set out below. Under the terms of the Northern Ireland Protocol, from 1 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). What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland. The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021: The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 September 2021: The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 January 2022: It is possible to register devices ahead of the above dates, but there is no legal obligation to do so. Under the new regulations; prior to placing a device on the market, importers and distributors have to: be able to demonstrate traceability of a product through NHS Supply Chain All content is available under the Open Government Licence v3.0, except where otherwise stated, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Legislation that applies in Great Britain, Requirements for those manufacturing and supplying devices in Great Britain, UKCA mark and Conformity Assessment Bodies, Regulation of medical devices in Northern Ireland, Placing a medical device on the EU market, Regulation of medical devices in Northern Ireland below, guidance on UK Responsible Persons below for more information, Further information on registration requirements for Northern Ireland is provided below, reporting adverse incidents and corrective actions to the, Further guidance on applying the UKNI marking, Check how the new Brexit rules affect you, Register medical devices to place on the market, Medical devices: conformity assessment and the UKCA mark, New guidance and information for industry from the MHRA, Moving goods into, out of, or through Northern Ireland, Coronavirus (COVID-19): guidance and support, Transparency and freedom of information releases, CE marking will continue to be recognised in Great Britain until 30 June 2023, certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023, the EU no longer recognises UK Notified Bodies, UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland) - and have become, a new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market, since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (, Class IIIs and Class IIb implantables, and all active implantable medical devices and, other Class IIb and all Class IIa devices and, Class I devices, custom-made devices and general, manufacturers of Class I devices, custom-made devices and general, if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market. Published a new section following European Parliament and Council decision to delay the full implementation of the Medical Device Regulation by one year to 26 May 2021. In summary, you need to use the UKNI marking if: The UKNI marking is sometimes referred to as the UK(NI) mark or the UK(NI) indication, including in Article 7(3) of the Northern Ireland Protocol. As these regulations did not take effect during the transition period, they were not EU law automatically retained by the EU Withdrawal Agreement Act and will therefore not automatically apply in Great Britain. Following last week’s announcement from the MHRA regarding changes to the regulation for devices to be marketed in the UK, we asked Translational Research Manager Dr Simon Eaglestone, who has represented the UCL Translational Research Office in various discussions around the new Medical Devices Regulation (MDR) for 2021, to … This includes devices placed on the market that are: Therefore, any enforcement or market surveillance powers available in respect of the UKCA mark also apply to CE marked devices placed on the Great Britain market. We are developing a robust, world-leading regulatory regime for medical devices that prioritises patient safety. We’ll send you a link to a feedback form. To place goods on the EU market, manufacturers must use the CE marking on its own, without the UKNI marking. The timelines for registering medical devices with the MHRA are set out below. The UK Government’s website published a The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. 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. This information is meant for guidance only. Added a link to guidance for manufacturers who don’t design or manufacture devices … Where an EU-based Authorised Representative is appointed, the manufacturer needs to register all device classes other than Class I devices, custom-made devices and general IVDs with the MHRA. For medical devices and IVDs, CE marking will continue to be used and recognised for the Northern Ireland market, and manufacturers based in Northern Ireland will not require an authorised representative established in the EU. The requirement to appoint a UK Responsible Person for the purposes of the Northern Ireland market does not apply where: Great Britain manufacturers are required to appoint an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation: From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements. You can change your cookie settings at any time. (EU Exit) Regulations 2020 sets out the specific requirements for Northern Ireland. UK Notified Bodies can conduct conformity assessments for the purposes of the Northern Ireland market. Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. You can also email devices.regulatory@mhra.gov.uk with questions. The UKCA mark is not recognised on the EU market. Where any changes to registrations are made, a £100 standard fee will apply per application. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023. The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. This page has been updated due to the end of the Brexit transition period. This means that the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented in Great Britain. However, such devices will need to be affixed with both a CE and a UKNI mark if mandatory conformity assessment has been undertaken by a UK Notified Body. Hence, the manufacturers registered outside the UK would have to … Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices. Don’t worry we won’t send you spam or share your email address with anyone. Medical Device Legislation . These are: These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). It will take only 2 minutes to fill in. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market. In such cases, the Northern Ireland-based Authorised Representative or UK Responsible Person is required to provide the MHRA with a list of device importers. Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions The MDR has a transitional period of four years and will fully apply from 26 May 2021. However, additional requirements for these devices must be met. Added a new section on COVID-19 medical devices guidance. Both the CE and UKCA mark can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. where the manufacturer is based in the UK or the Authorised Representative is based in Northern Ireland) must continue to register their devices on the same basis as they did previously as the above registration timings will not apply to these devices. We use this information to make the website work as well as possible and improve government services. As it stands, if the Commission’s proposal is passed, the UK MDR will come into effect prior to the MDR. Although the UKCA mark is available for use in Great Britain, a CE mark is needed for devices placed on the Northern Ireland market and EU rules need to be met. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, please see our published guidance. Where relevant, the number of the Notified Body or Approved Body must also appear on the label. Goods bearing the CE UKNI marking will not be accepted on the EU market. We use cookies to collect information about how you use GOV.UK. The new Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force on 25 May 2017. It is possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person that has a registered place of business in the UK. Please see our detailed guidance document for health institutions in Northern Ireland wishing to apply the exemption to their medical devices or IVDs. For some manufacturers the new regulation provides an … Government decisions required on the regulatory system act as both an Authorised Representative needs to and... 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