The manufacturer or his authorised representative (if the applicable legislation so provides) must keep documentation demonstrating that the product complies with the legal requirements. This must be kept for up to 10 years after the product is placed on the market. Note that this information, which varies depending on the specific legislation relevant to the product, may be requested at any time by market surveillance or law enforcement authorities to verify that the product complies with legal requirements. General records must be kept of: how the product is designed and manufactured; how the product has been shown to comply with the relevant requirements; and the addresses of the manufacturer and storage facilities. The information shall be kept in the form of a technical file which may be submitted at the request of a market surveillance authority. Further guidance is available on how the MHRA enforces medical device legislation. The UKCA mark is a product marking that can be used for medical devices placed on the UK market (England, Wales, Scotland). The UKCA mark is not recognised in the Northern Ireland market. Products placed on the market in Northern Ireland require the CE marking or the UKNI CE marking. You do not need to use the UKNI indication if you have self-certified your medical device or if you have used an EU-recognised notified body for mandatory third-party conformity assessment. Your QMS should contain all your evidence of compliance and, most importantly, be as easy to use as possible for you. A quality management system designed specifically for medical devices helps you keep all quality system data in order, demonstrate closed-loop traceability, and simplify compliance. In addition, from 1 January 2021, new MHRA registration requirements will apply to devices placed on the UK market.

Before panic breaks out, manufacturers need to know that the requirements will be introduced gradually according to the risk class. Another important step in the preparation process for manufacturers based outside the UK is the appointment of a UK Responsible Person (UKRP) registered with the MHRA. The name and registered office of the UKRP must appear on the label of the device next to the UKCA mark. The UKRP is also responsible for registering the manufacturer`s medical devices with the MHRA. The requirements are different for Northern Ireland, where an EU agent and an importer are still required for third-country companies to demonstrate that they comply with the requirements of the EU MDR or IVDR. This guide describes the conformity assessment process for medical devices and how you can mark your product. Following BREXIT and the expiry of transitional arrangements between the European Union (EU) and the United Kingdom on 31 December 2020, the UK government has published a proposal to regulate medical devices in the UK. Under the proposal, the Medicines and Healthcare Products Regulatory Authority (MHRA) will continue to recognise CE marks and certificates issued by notified bodies (NBs) based in the European Economic Area until 30 June 2023. However, manufacturers will need the new UK Conformity Assessment (UKCA) mark to apply from 1. July 2023 products on sale in England, Scotland and Wales. UKCA Assessment Bodies (CABs) – which are no longer NBs – will be designated by the MHRA from January 2021. In terms of labelling, all devices on the UK market must carry the UKCA label after 30 June 2023.

If you already have a valid CE marking on your device, you will not need to re-mark the device with a UKCA marking until 30 June 2023. It is acceptable for a product to bear both the UKCA marking and the CE marking before and after this date. Certain medical devices, IVDs and custom-made devices placed on the market in Northern Ireland must be registered with the MHRA. The exact requirements depend on the location of the manufacturer, the location of the authorized representative and the class of equipment listed below. For more information, see the MHRA Registration Policy. 12 months (until 31. December 2021) for the subset of Class I devices and general IVDs that do not already need to be registered with the MHRA under the existing rules – there is no grace period for Class I devices and general IVDs that already need to be registered with the MHRA; and Registration with the MHRA is currently required for certain medical devices (including IVDs, customised devices and systems or treatment packages) placed on the market in Northern Ireland. This requirement does not apply to manufacturers placing Class I medical devices or general IVDs on the Northern Ireland market if: *** The responsible person in the UK must be identified on the labelling, packaging or IFU of the product from 1 July 2023 if the new UKCA marking is required in addition to or replaces the EU CE marking.

Check out this MHRA information. Registration of customized products is carried out in accordance with the risk classification of the product. The responsibilities of the responsible person for the United Kingdom are set out in the 2002 MDR of the United Kingdom. In summary, in addition to the above registration requirements, the responsible person for the United Kingdom must: What you need to do to bring a medical device to market in the markets of Great Britain, Northern Ireland and the European Union (EU). You must declare that your Class IIa device complies with the requirements of the UK MDR 2002. You must also contact an accredited body to carry out a conformity assessment to approve your declaration. Where a third-party conformity assessment is required, a recognised body in the United Kingdom is required. However, manufacturers of non-sterile and unmeasured Class I devices and general IVDs can self-certify against the UKCA marking.

These guidelines apply only to medical devices and do not apply to other CE or UKCA marked devices that are subject to separate guidelines. Please note that requirements differ in the United Kingdom (England, Wales, Scotland) and Northern Ireland: The following calendar contains information on key dates, including requirements for registering products with the MHRA (please note that these are the current guidelines that may change during political and trade negotiations): Greenlight Guru is the only QMS solution, Developed by medical device professionals for medical devices. Get your free demo today. Please note that there is currently no UK Notified Body designated to carry out such assessments under the EU MDR or the EU IVDR. This section describes the criteria for affixing the UKNI marking to products if UK notified bodies are notified in the future. The MHRA may designate bodies accredited in the United Kingdom to carry out conformity assessments against the relevant requirements for the purposes of the UKCA marking. Since 1 January 2021, a number of changes have been introduced by secondary legislation on how medical devices are placed on the market in the United Kingdom (England, Wales and Scotland). Here`s what you need to know about the post-Brexit medical device landscape and its MHRA regulatory guardian for marketing a medical device in the UK: If you choose a UK Notified Body for mandatory third-party conformity assessment for the purposes of the Northern Ireland market, you will need to affix the UKNI mark in addition to the CE marking.