Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Under a no-deal Brexit, new products that have been CE-marked following conformity assessment by an EU27 notified body will still be allowed to be placed on the market in the UK for a “time-limited” period, the UK government says. ( (Also see "UK Publishes Medical Device No-Deal Brexit Contingency Legislation" - Medtech Insight, 25 Jan, 2019.))
But questions are being asked about who is responsible for registering those products, especially for those companies not based in the UK, and whether products already on the market before March 29 need to be registered too.
UK RPs – The Requirements
The full requirements of the UK Responsible Person are outline in Regulation 7A (Amendment of Part II of the 2002 Regulations) in the draft of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.
They include keeping certain information at the disposal of the MHRA such as declarations of conformity and technical documentation.
The UK’s MHRA confirmed to Medtech Insightthat to place a device on the UK market, manufacturers without a place of business in the UK will first have to appoint a UK responsible person (UK RP).
This UK RP needs to be physically located in the UK and acting on behalf of a manufacturer established outside the UK (i.e. including manufacturers in the EU27 post-Brexit). ( (Also see "UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit " - Medtech Insight, 9 Jan, 2019.))
They carry out specified tasks on behalf of the manufacturer, including registering products with the MHRA before the device is placed on the UK market.
After Mar. 29, 2019, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. This is an extension of existing registration requirements. ( (Also see "Brexit At The 11th Hour: UK Refreshes No-Deal Guidance For Medtech " - Medtech Insight, 4 Jan, 2019.))
Critically, products that have already been “placed on the market” – an EU term that has just been explained in some detail by the European Commission – before March 30 will not need to be registered, the UK MHRA toldMedtech Insight ( (Also see "European Commission Answers Vital Questions In Second Major Brexit Response " - Medtech Insight, 22 Feb, 2019.))
The recent explanation by the European Commission of what “placed on the market” means, suggests, among other things, that goods held in the EU27 by a wholesaler, or on the shelf of a store, by the UK’s withdrawal date from the EU are considered placed on the market. The Commission also stresses that the concept of placing on the market addresses:
For all new devices, there will be grace periods to allow time for compliance with the new registration process, with high-risk devices being prioritized under staggered deadlines after Mar. 29, and specifically within:
Four months, for class III medical devices, class IIb implantable medical devices, active implantable medical devices, and IVDs in List A;
Eight months, for class IIb non-implantable medical devices, class IIa medical devices, IVDs List B, and self-test IVDs; and
12 months, for class I medical devices, self-certified IVDs, and class A IVDs.
New guidance has just been published by the MHRA on regulating medical devices in the event of a no deal scenario . Medtech Insight will be posting a piece providing information on the latest detailed requirements for registration within the next 24 hours, including details about registration fees.
Medtech Insight: global medical technology news & analysis
By Amanda Maxwell 23 May 2022
This is a landmark month with the expiry this week of the IVD Directive. May has also seen a flurry...
Medtech Insight: global medical technology news & analysis
By Amanda Maxwell 23 May 2022
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor...
Medtech Insight: global medical technology news & analysis
By Shawn Schmitt 23 May 2022
The makers of breathing machines said in comments to the US agency that it must address language in its draft...
Request a Trial
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
Speak to Sales
Our team is ready to hear from you for a particular request or area of interest. Please do not hesitate to reach out and discuss.
Client Services
Contact us for product technical and account support.
Pharma Report Store
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now:
In the continually evolving medtech competitive landscape, it is vital to stay up-to-date with key events. With Meddevicetracker, you’ll be able to anticipate upcoming filings, research clinical trial dates and data, and access market size information and expert forecasts, all in one place.
Get a window into what the leading players across the biopharma, medtech, and diagnostics industries are thinking, as well as important insight into what your competitors are doing. Build your strategy with In Vivo.
Looking for more products Product Finder
