It will take only 2 minutes to fill in. © Hogan Lovells var today = new Date(); var yyyy = today.getFullYear();document.write(yyyy + " "); | Attorney Advertising. The UKCA requirements are still being developed and will "take into consideration international standards and global harmonisation". The Medical Devices and the In-Vitro Diagnostic Devices Regulations have introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device. When that period expires on 31 December 2020, existing EU legislation will be automatically incorporated into UK domestic legislation to the extent possible. The UKCA route will be optional from 1 January 2021 and mandatory from 1 July 2023. Medical devices regulation and safety: detailed information ... To help us improve GOV.UK, we’d like to know more about your visit today. While the Guidance clarifies many aspects of the post-transition regulatory environment for medical devices in the UK, there are still some areas to clarify and further guidance, including on the UKCA route and UK RPs, is anticipated in the coming months. From 1 January 2021 onwards, it will not be possible to place new devices on the EU market unless the conformity assessment has been conducted by an EEA-based Notified Body. To embed, copy and paste the code into your website or blog: Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra: [HOT] Read Latest COVID-19 Guidance, All Aspects... [SCHEDULE] Upcoming COVID-19 Webinars & Online Programs, [GUIDANCE] COVID-19 and Force Majeure Considerations, [GUIDANCE] COVID-19 and Employer Liability Issues. See coming into force provision and notes, where … Adam Stanley examines how Brexit and COVID-19 have conspired to shape the future of the regulatory market for medical devices in the UK.. The Guidance set outs out how devices will be certified, conformity marked and registered in GB and Northern Ireland, which together make up the UK, from 1 January 2021. In order to be … Liaising with the MHRA, including providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device on request, reporting suspected incidents and co-operating on any preventive or corrective actions. UK medical device regulation after Brexit. The UK left the EU on 31 January 2020 and existing EU medical device legislation has continued to apply in the UK under the terms of the EU-UK Withdrawal Agreement during the Brexit transition period. Different rules will apply in Northern Ireland than in GB as a result of the Northern Irish Protocol (see below). We use this information to make the website work as well as possible and improve government services. From 1 January 2021, UK Authorised Representatives and certificates issued by UK Notified Bodies will no longer be recognised in the EEA. The registration of custom-made devices will be in line with the risk classification of the device. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. In May 2017, the European Commission published the new Medical Device Regulation 2017/745, which combined both Active Implantable Devices and General Medical Device Directives into one document. From 1 January 2021, devices manufactured in the UK but destined for the EU market will need to adhere to the relevant EU legislation and bear the CE mark. 31 March 2020. 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