With just about a month left until Brexit, the UK regulatory authority for medical products issued updated guidance on what the medical device industry needs to know about the future device regulation under the increasingly likely scenario of Britain leaving the EU without a deal on continuing resolutions.
From requiring a new role as a UK Responsible Person and additional importing and distributing obligations to a slew of new registration and classification requirements, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) fleshed out guidance from January on the no-deal scenario. The 18-page guidance document was issued on Tuesday and is intended to apply on the UK’s 29 March exit day.
Securing a deal has been a priority for MHRA in Brexit negotiations. British members of Parliament rejected
Prime Minister Theresa May’s proposed Brexit deal in January after May’s government and the EU struck the withdrawal agreement last November. May is reportedly
embracing the prospect of a delayed exit.
But the MHRA guidances that have trickled out in recent months on no-deal Brexit preparations are seemingly time-sensitive, with deadlines for industry to comply with new requirements in medical device regulations set as early as the same day of Britain’s exit. “We are intensifying and accelerating no deal planning to ensure we are fully prepared,” MHRA said. The new guidance’s proposals remain subject to parliamentary approval on the relevant statutory instruments prior to bringing these proposals into law. This was first discussed via the Brexit no-deal guidance
, which largely focused on pharmaceuticals and clinical trials, that MHRA issued in January with just a few details on devices.
UK MDR 2019
While MHRA is still committed to settling on a withdrawal agreement, industry should not hold its breath. The new requirements would come as a result of amendments to directives established in EU regulations by operation of the UK’s version of the EU medical device regulation (MDR)—UK MDR 2019.
As the January guidance previously stated, the UK intends to have established a regulatory system that mirrors the key elements of both EU MDR and the EU In Vitro Diagnostic Regulations (IVDR) just one day after the Brexit deadline. The draft statutory instruments required for the UK to bring these regulations into force were recently brought before Parliament for approval. MHRA will follow the same transitional periods set to comply with the new requirements under MDR/IVDR by May 2020 and 2022, respectively.
Part VIII or Part IX of the current UK MDR 2002 transfer relevant requirements from the EU MDR/IVDR as amended by UK MDR 2019. They place additional responsibilities on manufacturers to comply with the new regulations. These include classifying a device against new risk classification criteria, meeting labeling and technical documentation requirements as well as those on quality management systems.
Manufacturers will also face more requirements on postmarketing surveillance and vigilance, beginning in 2020 and 2022 for MDR and IVDR, respectively. “This will include maintaining a post-market surveillance plan and issuing periodic safety update reports,” MHRA said. “Additionally, the new vigilance requirements define specific reporting requirements which include but are not limited to defined time frames for notifying the MHRA of incidents and the preparation of manufacturer reports after the occurrence of incidents.”
From 29 March, the new role for a UK Responsible Person will be required to act on behalf of a medical device manufacturer established outside of the UK. The new guidance offers a slightly more detailed look into the expectations for this new role, which was first reported in last month’s guidance. It specifies some of the responsibilities of the new role, including registering with MHRA prior to placing devices on the UK market and providing documented evidence in support of the designated position.
In addition to the new registration process initially set forth in January and detailed via the new guidance, another significant change involves UK MDR 2019’s changes to medical device classification rules. This will introduce four new rules and modify certain existing rules. “In terms of IVDs, a brand-new classification system will be introduced with the aim of classifying IVDs based on the risk they present,” MHRA said. The new system will phase in seven new classification rules by May 2022 under which all IVDs must be classified into one of four classes according to their potential risk. Device types that are not currently regulated as medical devices, such as contact lenses, will be subject to such regulation beginning next May.
The new guidance also described the situations in which manufactures will be charged a fee of £100 per registration application or for changes to existing registration details. Renewals will be required each year.
Yet there are also certain areas under the post-Brexit regulatory landscape for medical devices as currently defined in the draft regulations and MHRA’s new guidance that are likely to be well-received by industry. Existing certificates issued by UK-based notified bodies (NBs) will retain their validity after 29 March. MHRA will also continue to allow CE marked medical devices to be placed on the UK market.
Other clarifications relate to placing devices on either the UK or EU market post-Brexit. An NB based in an EU Member State is needed to place new devices on either market. A manufacturer with a UK-based authorized representative will need a new one in an EU country to place a new device on the EU market.
The additional obligations to be imposed on importers and distributors as of 29 March include ensuring the device has been CE marked and is registered with MHRA. Other changes facing industry from 29 March relate to set statutory definitions, including for adverse events and CE marking, among others.
Click the timeline below for an overview of upcoming compliance deadlines in full screen.
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe