All medical devices, IVDs and custom-made devices must be registered with the MHRA before being placed on the Great Britain market. 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. Where third party conformity assessment is required, a UK Approved Body is needed. The MHRA is responsible for the designation and monitoring of UK Conformity Assessment Bodies. See below for guidance on the UKCA mark and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information. 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. Goods bearing the “CE & UKNI” marking will not be accepted on the EU market. ... States from 26 May 2020 … 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. The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). Added a link to our consultation on the Health institution exemption for IVDR/MDR. 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. Great Britain is England, Wales and Scotland. Added a new section on COVID-19 medical devices guidance. 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. Devices must be registered in line with the timings set out below. 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 regulations have introduced a Unique Device Identification (UDI) System. We’ll send you a link to a feedback form. 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. Added a one-page guide to outline to key changes in the new MDR IVDR which affect health institutions. We will continue our engagement with stakeholders within the life sciences and healthcare sectors on this proposed regime. It is possible for manufacturers to register devices of different classes, that are subject to different registration dates, at the same time. Importers and distributors are not required to appoint a UK Responsible Person. 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 MHRA can designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark. 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. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating medical devices. 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. We use this information to make the website work as well as possible and improve government services. In such cases, the UK Responsible Person is required to provide the MHRA with a list of device importers. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. 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. Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices, including IVDs. Please see guidance below on Northern Ireland for further information. These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System. We will take into consideration international standards and global harmonisation in the development of our future system. In addition, new classification rules were enforced and the regulations now include products without a medical purpose. You can change your cookie settings at any time. These classification rules will change from 26 May 2020 (for medical devices) and 26 May 202… Goods bearing the CE UKNI marking will not be accepted on the EU market. They must also take appropriate safety action when required. According to the applicable regulations, starting from January 1, 2020, any and all medical devices intended to be marketed in the UK should be duly registered with the MHRA. We use cookies to collect information about how you use GOV.UK. 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. To help us improve GOV.UK, we’d like to know more about your visit today. 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. 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. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark. Companies within the UK will still be in scope when the EU MDR comes into effect, however, … 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 will be enabled through the powers created through the Medicines and Medical Devices Bill. 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. Further guidance is available on how the MHRA enforces the legislation on medical devices. Medical devices placed on the Great Britain market must have a UKCA mark or a CE marking, depending on which legislation the device has been certified under. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, please see our published guidance. Medical devices constitute Part 3 of the Bill, with chapters on regulations, enforcement, and disclosure of information. 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. “ “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. The UKCA mark is not recognised on the EU market. UK regulation of medical devices from 1 January 2021. Added new section on Guidance for Annex XVI manufacturers and added PDF attachment. We use cookies to collect information about how you use GOV.UK. These Regulations (in the form in which they existed on 1 January 2021) continue to have effect in Great Britain after the transition period. 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. Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices. The new regulations include obligations that health institutions will need to meet by 26 May 2020 for medical devices … To help us improve GOV.UK, we’d like to know more about your visit today. For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. If you are a Great Britain-based manufacturer and wish to supply CE marked devices to the EU market, you must appoint an Authorised Representative based in the EU or Northern Ireland, to register and act on your behalf. During the … This means that since 1 January 2021, the Great Britain route to market and UKCA marking requirements is still based on the requirements derived from current EU legislation. The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR) will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. If you are a manufacturer based outside the EU and you currently have only a Great Britain-based Authorised Representative, you must appoint an Authorised Representative based in the EU or Northern Ireland. Introduction Definitions Classification Conformity assessment Placing a device on the market UDI and Eudamed Supply chain obligations PMS and vigilance Contact Introduction - How to use this guide Navigate … 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. Schedule 1 of the Medical Devices (Amendment etc.) In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices. As it stands, if the Commission’s proposal is passed, the UK MDR will come into effect prior to the MDR. 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 … 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. It will take only 2 minutes to fill in. Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. To place a device on the EU market you must adhere to the relevant EU legislation and affix a CE mark to demonstrate compliance. Other than the above requirement, there are no additional obligations on distributors or suppliers of medical devices. 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 can use the UKCA mark on a voluntary basis until 30 June 2023. News - Medical Devices UK; 2020 Medical Device News; SHARE. 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. 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. However, additional requirements for these devices must be met. Medical devices are given a classification depending on the level of risk associated with them. Medical Device Legislation . The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market. The results of conformity assessments carried out by UK Notified Bodies are not recognised within the EU. Where a medical device was already registered with the MHRA before 1 January 2021, it does not need to be re-registered. you are placing certain medical devices on the Northern Ireland market; and, your goods require mandatory third-party conformity assessment; and. We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. For some manufacturers the new regulation provides an … 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. Therefore, Northern Ireland businesses can continue to place CE and CE UKNI marked devices on the Great Britain market after 30 June 2023. 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. Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. Further guidance on device registrations. Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative needs to register all device classes with the MHRA. We recommend you familiarise yourself with the legislation that is applicable to your devices: If you are manufacturing or supplying a medical device, you must meet new obligations set out in the Regulations, including, but not limited to, ensuring that: We have created an interactive guide to the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) (PDF, 7.03MB, 27 pages). Medical Devices. Hence, the manufacturers registered outside the UK would have to … Where any changes to registrations are made, a £100 standard fee will apply per application. You’ve accepted all cookies. The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. UK government publishes new draft legislation on medicines and medical devices By Adela Williams & Louise Strom on February 20, 2020 Posted in Brexit, Clinical Trials, MDR, Medical Devices, MHRA The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. Further guidance on applying the UKNI marking. The Medical Devices (Amendment etc.) This publication is heralding a new era of control and requires that the Medical Device … Class I manufacturers can continue to self-declare their conformity against the MDR from 26 May 2021. 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. 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). 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. This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance. Trending. These terms refer to the same marking. You can also email devices.regulatory@mhra.gov.uk with questions. 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. The importer’s name and address does not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA mark. The interactive guide will help new and experienced manufacturers navigate their obligations under new EU regulations on medical devices. The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. 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 We’ll send you a link to a feedback form. This information is meant for guidance only. However, if the two parties do not agree on exit terms by March 2019, this implementation period will be off the … 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). UK Responsible Person details do not need to be included on labelling for CE marked devices. you are a manufacturer based in Great Britain, you are a manufacturer based in Northern Ireland, your Authorised Representative is based in Northern Ireland, you only intend to place a Class I medical device, custom-made medical device or general, if your device was placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market, you are not able to place a device on the EU market unless it has been assessed by an EU-recognised Notified Body. Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023. Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. The UK Government’s website published a Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods. 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. 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. (EU Exit) Regulations 2020. 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. There is a requirement, in most cases, to register devices with the MHRA and have a UK Responsible Person if the manufacturer is based outside the UK, as set out below. As noted above, to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person that is established in the UK. Added a link to guidance for manufacturers who don’t design or manufacture devices … We use this information to make the website work as well as possible and improve government services. Further information on registration requirements for Northern Ireland is provided below. In cases where the Great Britain importer is not the UK Responsible Person, the importer is required to inform the relevant UK Responsible Person of their intention to import a device. As part of these discussions, we are identifying and prioritising elements of international practice that promote public health and patient safety. The Bill also allows hospitals to develop individualized treatments for patients with unique conditions, and it widens the range of professions eligible to prescribe medicines in low-risk situations. Any mandatory third-party conformity assessment for the CE marking must be carried out by an EU-recognised Notified Body. 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. 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). The MHRA has published guidance on implementing the Health Institution Exemption in Northern Ireland. With patient health and safety as a guiding principle, the Council and the Parliament adopted on 23 April 2020 Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions. Products currently requiring a CE marking will still need a CE marking for sale in the EU. We will provide guidance on this in due course in light of Government decisions required on the future of UK regulation. See the guidance on conformity assessment bodies for further information. 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. The new EU Medical Device Regulations (MDR) were established on the 25 th May 2017 with full application of the MDR coming into effect on the 26th May 2020. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA. 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 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. For medical devices, this means that any conformity mark held by a Northern Ireland business which validates a device for sale on the Northern Ireland market is valid for the whole of the UK market. This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 (as amended). The Independent Medicines and Medical Devices Safety Review, which delivered its report in July 2020, has highlighted the importance of strengthened regulations that do more to … The manufacturer must ensure their device meets appropriate standards of safety and performance for as long as it is in use. The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively. 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. The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Once fully applied, they will replace the medical device, in vitro diagnostic medical device and active implantable medical device Directives. Risk classification rulesset out in the legislation determine which risk class the device falls into. 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. Requirements for appointing a UK Responsible Person to place devices on the Northern Ireland market are covered separately below. You must ensure that your device meets EU labelling requirements in order to place it on the EU market. The necessary common specifications shall be adopted by 26 May 2020. We are taking steps to plan for after the end of the transition period. (Amendment etc.) More information on registrations (including fees) can be found in the MHRA’s registrations guidance. If you use a UK-based Notified Body to conduct any mandatory third-party conformity assessment for your device, the following will apply: The results of mandatory conformity assessment carried out by UK Notified Bodies are not recognised by the EU. Where applicable, Class I devices, custom-made devices and general IVDs must be registered from 1 January 2021. Further guidance on applying the UKNI marking. The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK. By Alina Shrourou, on 9 September 2020. Guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland). 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. You should consider whether you need separate professional advice before making specific preparations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations … If you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA mark until 1 July 2023 for placement on the Great Britain market. Device manufacturers must never apply the UKNI marking on its own - it must always accompany a CE marking. Great Britain-based Authorised Representatives are no longer recognised in the EU. 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. Don’t include personal or financial information like your National Insurance number or credit card details. 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. UK Notified Bodies can conduct conformity assessments for the purposes of the Northern Ireland market. 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. We are committed to improving the standards and scrutiny of medical devices that reach UK patients. 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. Business in the legislation on medical devices market to be valid for the and... 1 July 2023, a £100 standard fee will apply per application Britain, Northern Ireland, different apply. 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