Euro Roundup: MHRA plans wave of medtech regulation after consultation shows support for reform

| 30 June 2022 | By Nick Paul Taylor 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to introduce a wave of regulations to reclassify medical devices, strengthen postmarket surveillance and otherwise revise its approach to medtech after seeing support for reform in the 891 responses to its 2021 consultation.
MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safety, increase transparency, more closely align the UK with international practices and make MHRA’s regulations more flexible, responsible and proportionate (RELATED: MHRA floats overhaul of medical device regulation in public consultation, Regulatory Focus 20 September 2021).
After feedback, the UK government has published its response.
“MHRA received strong support for proposals that will improve patient safety and safeguard public health, for example, through modernizing the scope and classification rules of medical devices to deliver improvements in the safety of all medical devices. It also raised points around identified inequities within clinical investigations,” said Sajid Javid, secretary of state for health and social care. “MHRA will look to address these points within the regulations and supplementary guidance to support this review.”
Seventy percent of the respondents backed MHRA’s proposed changes to the rules for classifying medical devices. Specific details received pushback, for example over the burden and costs of changes to active implantable devices.
MHRA will also work to strengthen postmarket surveillance after finding broad support. The consultation found 93% of respondents agree manufacturers should implement a postmarket surveillance system based on a post-market surveillance plan, “which collates and utilizes information from a range of sources.” There was also widespread support for the regulations providing a detailed outline of what the plan should address and what postmarket clinical and performance follow-up should include.
The government response also establishes transitional arrangements for the changes. One key question going into the consultation was how to ensure a smooth transition to the new regulatory framework. After reviewing the feedback, the government plans to introduce transitional arrangements for both UK Conformity Assessed (UKCA) and CE marked medical devices.
For UKCA marked devices, the government plans to allow products to be placed on the market until the certificate expires or for three years after the regulations take effect, for medical devices, or for five years, for in vitro diagnostics (IVDs). If the certificate expires before the three or five-year window is up, the transitional arrangements will end. The government has proposed similar arrangements for devices and IVDs with CE marks. Sponsors of clinical trials that straddle the old and new regulations will not need to reapply to MHRA but will need to comply with the new reporting requirements.
Press Release, Government Response, Javid Statement
EU bodies reach agreement on cross-border cooperation to counter public health threats
The European Parliament and Council have reached a provisional agreement on handling cross-border health threats, setting the stage for the introduction of clearer rules on joint procurement of medicines and medical devices.
In response to problems early in the pandemic, the European Commission proposed strengthening the health security framework in November 2020. The legislative process is now nearing its conclusion, with the Parliament and Council just needing to formally approve an agreement that includes the possibility to limit parallel procurement and negotiation for products purchased at the European Union level.
To ensure transparency, the agreement requires the Commission to inform Parliament about all joint procurement procedures and grant it access to the relevant contracts. The goal is to enable stronger EU cooperation and timely development, stockpiling and joint procurement of medical countermeasures.
Press Release
EMA asks companies to register Industry Single Point of Contact on supply and availability
The European Medicines Agency (EMA) has called for marketing authorization holders to register their Industry Single Point of Contact (i-SPOC). Under regulations intended to reinforce the role of EMA, the contacts will inform the agency about the supply and availability of critical medicines in crisis situations.
EU officials established the i-SPOC requirement in response to the COVID-19 pandemic. Now, when there is a “public health emergency” or “major event,” the i-SPOC will facilitate communication between the marketing authorization holder and EMA to “detect, report, and prevent or manage supply and availability issues of medicines included in a list of critical medicines.”
EMA published a list of critical medicines for COVID-19 earlier this month. The list includes authorized COVID-19 vaccines, such as Pfizer’s Comirnaty and Moderna’s Spikevax, alongside medicines for treating the disease.
Companies have until 2 September to register their i-SPOC on EMA’s IRIS online platform. EMA expects the two-step i-SPOC registration process to take as long as 10 working days.
EMA Notice
Life science industry bodies back push to improve oversight of third-party litigation funding
EFPIA, MedTech Europe and other trade organizations have backed calls for “sensible safeguards” on third-party litigation funding (TPLF). The groups want to protect parties from “opportunistic litigation.”
TPLF allows hedge funds and other private financiers to confidentially fund lawsuits and arbitration in return for a split of any settlement or award. Globally, the trade groups estimate the market is worth up to €80 billion ($84 billion), with more than 100 litigation funders operating in Europe.
The limited regulation of TPLF in the EU led the European Parliament to call on the Commission to revise the oversight of the sector. Parliament recommended “a system of authorization for litigation funders” as part of a push to manage some of the perceived problems of TPLF.
“With no obligation to see cases through to the end and no responsibility for adverse costs, funders can pursue opportunistic claims for a high reward with low risk. Faced with years of litigation, expensive legal bills, and reputational risk, defendants may be forced to settle even unmeritorious claims,” the trade groups wrote.
Joint Statement
Other news:
EMA has started a review of Bavarian Nordic’s Imvanex in monkeypox. The vaccine currently is authorized for use against smallpox. Supplies of Imvanex in the EU are “very limited,” according to EMA, leading the agency’s Emergency Task Force (ETF) to consider allowing the use of Jynneos, its US sibling. Although Jynneos is unauthorized in the EU, the ETF has recommended its use in protecting against monkeypox, in part on the strength of the US Food and Drug Administration's position. EMA Notice, More
EMA has published a report on the data quality framework for medicines regulation workshop that it held earlier this year. The report describes the findings of a set of breakout sessions, which considered questions such as how to strengthen existing regulatory requirements to produce higher-quality data. Attendees identified a need for increased interaction between regulators and manufacturers early in the product development lifecycle and a need to leverage clinical trial data for secondary use. The workshop will inform the creation of a data quality framework this year. Workshop Report


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