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.))
"Placed On The Market" – Term Explained
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:
- Each individual product, not a type of product; and
- The first instance making a product available on the EU27 market, i.e., the first supply of a good for distribution, consumption or use, after the manufacturing stage.
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:
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Four months, for class III medical devices, class IIb implantable medical devices, active implantable medical devices, and IVDs in List A;
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Eight months, for class IIb non-implantable medical devices, class IIa medical devices, IVDs List B, and self-test IVDs; and
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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.
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