It will take only 2 minutes to fill in. This means that they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market. Manufacturers can use the UKCA mark on a voluntary basis until 30 June 2023. 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. Most medical devices, IVDs and custom-made devices that are placed on the Northern Ireland market need to be registered with the MHRA. The timelines for registering medical devices with the MHRA are set out below. However, manufacturers (or their UK Responsible Person) are required to review the information held by the MHRA to ensure it remains correct in line with the above dates. Importers and distributors are not required to appoint a UK Responsible Person. Health institutions wishing to apply the exemption under the new Regulations will need to ensure that: The full requirements of implementing the healthcare institution exemption can be found in Article 5(5) of the MDR and IVDR. Please see guidance below on Northern Ireland for further information. 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. All decision… However, additional requirements for these devices must be met. Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically, without having to undergo a new designation process. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern Ireland following the expiry of the Brexit transition period under the EU-UK … Where any changes to registrations are made, a £100 standard fee will apply per application. Please direct any queries on the new Regulations to. These Regulations are made in exercise of the powers in sections 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a)) arising from the withdrawal of the United Kingdom from the European Union, and in order to give effect to the Protocol on … Trending. UK MHRA issues new guidance on UK REP and medical device regulatory compliance Sep 3, 2020 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain (and Northern Ireland and European Union (EU)) starting January 1, 2021. 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 then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain. We will consult on any future changes to this. Trending . Products currently requiring a CE marking will still need a CE marking for sale in the EU. We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. 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 See the guidance on conformity assessment bodies for further information. The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 (as amended). Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. It will take only 2 minutes to fill in. As part of these discussions, we are identifying and prioritising elements of international practice that promote public health and patient safety. This information is meant for guidance only. Schedule 1 of the Medical Devices (Amendment etc.) Where applicable, Class I devices, custom-made devices and general IVDs must be registered from 1 January 2021. You can also email devices.regulatory@mhra.gov.uk with questions. We are taking steps to plan for after the end of the transition period. News - Medical Devices UK; 2020 Medical Device News; SHARE. Goods bearing the CE UKNI marking will not be accepted on the EU market. For some manufacturers the new regulation provides an … Given that this is an extension of existing registration requirements, there is a grace period to allow time for compliance with the new registration process. This applies to devices of all classes. 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. More information on registrations (including fees) can be found in the MHRA’s registrations guidance. Where a UK Notified Body has been used for your conformity assessment, you must place a CE UKNI mark on the device. Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. However, if the two parties do not agree on exit terms by March 2019, this implementation period will be off the … As covered previously, the UK Parliament is in the process of advancing the Medicines and Medical Devices Bill, which would form the foundation of a post-Brexit framework for medical device regulation.The bill was passed at the Second Reading before the House of Commons on March 2 and will next be reviewed by a Public Bill Committee. During the … This publication is heralding a new era of control and requires that the Medical Device … Added a link to guidance for manufacturers who don’t design or manufacture devices … The MHRA will only register devices where the manufacturer or their UK Responsible Person has a registered place of business in the UK. Please note that since publication of the above guide the implementation timeline of the MDR has been delayed and will now fully apply from 26 May 2021 in Northern Ireland. The new Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force on 25 May 2017. For Northern Ireland, different rules apply to those in Great Britain. UK Responsible Person details do not need to be included on labelling for CE marked devices. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 (postponed to May 26 th 2021) to meet the requirements of the regulation. Where allowed for in the relevant legislation, you can CE mark your device on the basis of self-certification for the purposes of the Northern Ireland market. 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. UK regulation of medical devices from 1 January 2021. This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). See the guidance Using the UKCA mark for further information. Devices placed on the Northern Ireland market must meet EU labelling requirements. Risk classification rulesset out in the legislation determine which risk class the device falls into. The government has set up a new domestic UK database, UK Market Conformity Assessment Bodies, to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System. The Medical Devices (Amendment etc.) Added new section on Guidance for Annex XVI manufacturers and added PDF attachment. This page has been updated due to the end of the Brexit transition period. All medical devices, IVDs and custom-made devices must be registered with the MHRA before being placed on the Great Britain market. See guidance on UK Responsible Persons below for more information. These terms refer to the same marking. Device manufacturers must never apply the UKNI marking on its own - it must always accompany a CE marking. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating medical devices. Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body in order to be affixed with the UKCA mark and placed on the Great Britain market. 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. This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance. Where third party conformity assessment is required, a UK Approved Body is needed. This will be enabled through the powers created through the Medicines and Medical Devices Bill. For example, manufacturers (or their UK Responsible Person) can register their Class IIa medical devices at the same time as registering their Class III medical devices. if the manufacturer acts contrary to its obligations under these Regulations: terminate the legal relationship with the manufacturer; and, CE marked in conformance with the EU MDD, EU IVDD or EU AIMDD, CE marking is required. The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market. As it stands, if the Commission’s proposal is passed, the UK MDR will come into effect prior to the MDR. The new EU Medical Device Regulations (MDR) and In Vitro Diagnostics Devices Regulations come into force from 25 May 2020 and 25 May 2022 respectively. This guidance provides information on the UK system, including for: This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Check how the new Brexit rules affect you. Please see the MHRA’s guidance on registrations for more information. “ “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. Added a one-page guide to outline to key changes in the new MDR IVDR which affect health institutions. Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023. For the purposes of the CE mark, an EU-recognised Notified Body, where required, must be used. The MHRA has published guidance on implementing the Health Institution Exemption in Northern Ireland. ... States from 26 May 2020 … you are placing certain medical devices on the Northern Ireland market; and, your goods require mandatory third-party conformity assessment; and. Companies within the UK will still be in scope when the EU MDR comes into effect, however, … The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market. In order to be eligible to apply for the registration of a medical device, the manufacturer shall have a 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. Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs. UK Approved Bodies are not able to conduct conformity assessments in relation to the CE marking other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland. For the purposes of the Great Britain market, UK Approved Bodies can conduct conformity assessments in relation to the UKCA 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 amended). This is the case even if the assessment was carried out before 1 January 2021, unless your product had already been placed on the EU market before 1 January 2021. The membership of the … 31 March 2020. In addition, the UKNI marking is required if a UK Notified Body undertakes mandatory third-party conformity assessment, certain medical devices, including in vitro diagnostic medical devices (, when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative. It is possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person. See below for guidance on the UKCA mark and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information. Further information on registration requirements for Northern Ireland is provided below. Further guidance on applying the UKNI marking. Where certificates have been issued by a UK Notified Body, the Notified Body has been re-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. Don’t include personal or financial information like your National Insurance number or credit card details. 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. 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. 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. To place goods on the EU market, manufacturers must use the CE marking on its own, without the UKNI marking. (EU Exit) Regulations 2020. You must appoint a single UK Responsible Person within the UK for devices that are placed on the Northern Ireland market if you are an EU or EEA-based manufacturer. The UKCA mark is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE mark for sale in these markets. Registration for custom-made devices is in line with the risk class of the device. The MHRA is responsible for the designation and monitoring of UK Conformity Assessment Bodies. Association of British HealthTech Industries (ABHI): British In Vitro Diagnostics Association (BIVDA): Proprietary Association of Great Britain (PAGB). From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to act as the Competent Authority for medical devices in Northern Ireland. Further detail on the, Class IIb non-implantable medical devices, 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, where they have samples of the devices or access to the device, comply with any request from the, where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the, 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 appointed. You must ensure that your device meets EU labelling requirements in order to place it on the EU market. 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 … To help us improve GOV.UK, we’d like to know more about your visit today. In this particular case, devices would need to be registered from 1 May 2021 in line with the timings for registering Class III devices. The necessary common specifications shall be adopted by 26 May 2020. 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. 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. Hence, the manufacturers registered outside the UK would have to … However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling where the UKCA mark has been affixed (including when devices have been dual marked). Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices. Where allowed for under the relevant legislation, you can CE mark your medical device on the basis of self-certification for the purposes of the EU market. Any mandatory third-party conformity assessment for the CE marking must be carried out by an EU-recognised Notified Body. (Amendment etc.) The interactive guide will help new and experienced manufacturers navigate their obligations under new EU regulations on medical devices. You’ve accepted all cookies. The MHRA can designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark. To help us improve GOV.UK, we’d like to know more about your visit today. Previous obligations around storage, transportation and checking device labels for the CE marking or UKCA marking continue to apply. The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices. 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 manufacturer must ensure their device meets appropriate standards of safety and performance for as long as it is in use. 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. The exemption for manufacturing or modifying and using medical devices or IVDs within the same health institution (also known as ‘in house manufacture’) will continue to apply. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods. Medical device regulatory requirements are undergoing a period of transition, with the new Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostics Regulation 2017/746 (IVDR), both having been officially published in May 2017 by the European Commission. Class I manufacturers can continue to self-declare their conformity against the MDR from 26 May 2021. In addition, new classification rules were enforced and the regulations now include products without a medical purpose. 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. To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The EU Medical Device Regulation is currently scheduled to come into effect in May 2020, which puts it firmly in the middle of the Brexit transition period. For other device classes the timings are as follows: 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. 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. Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). We will take into consideration international standards and global harmonisation in the development of our future system. 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. This will be followed by a formal public consultation with the aim of delivering an attractive world-class regulatory system. In March 2018, the EU and the UK came to an agreement that introduced a 21-month implementation period, during which the UK would continue to operate under many of the same regulations as the EU, including those that govern the medical device market. 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 … Added a new section on COVID-19 medical devices guidance. 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