Euro Roundup: MHRA shares guidance on incoming changes to medtech postmarket surveillance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the interpretation and implementation of incoming changes to the postmarket surveillance (PMS) rules for medical devices.

Legislation passed late last year introduces clearer, more stringent PMS requirements proportionate to each device's risks. The new law improves regulatory oversight, increases the scope of devices subject to PMS requirements, and requires manufacturers to have a postmarket surveillance plan and system. It comes into force on 16 June.

MHRA has published a suite of guidances to help companies adapt and is encouraging affected businesses to start complying immediately. The suite includes guidance on implementing the requirements; on vigilance systems and periodic safety update reports; and a set of documents about specific rules for certain types of devices such as insulin pumps and breast implants.

The implementation document clarifies key terms such as “lifetime of a device” and “PMS period.” The clarifications confirm that manufacturers should collect PMS data from “when the first is available for use, to the end of the lifespan when the last of these devices could reasonably remain in use.”

Another section addresses the need for manufacturers to have a PMS system capable of “gathering and analyzing feedback and complaints,” according to MHRA. The agency wants companies to continue undertaking postmarket surveillance at the end of the PMS period because “new safety or performance issues can continue to arise at any point the device potentially remains in use.”

“MHRA recognises that the manufacturer can only validate the performance and safety of their device for the specified device lifetime,” the agency said. “The purpose of extending postmarket surveillance is to gain important insight into device performance beyond the known and characterized period, which could be used to enhance patient safety.”

Manufacturers must define the PMS system within a PMS plan proportionate to the risk posed by a device. The PMS plan requirement is mandatory. The plan must specify the objectives of the PMS system, the processes for gathering information, methods of data analysis, and more. Patient and public engagement is now a requirement for PMS plans.

The final section of the implementation guideline addresses reporting under the new regulations. The section describes the type of information manufacturers must report and the deadlines for getting the information to MHRA. The deadline for notifying the agency of an anticipated serious deterioration in health is now 15 calendar days, compared to 30 days under the old requirements.

Press Release, MHRA Guidance

Notified body bottleneck eases, but other MDR, IVDR issues persist, survey shows

A survey of more than 200 medical device and in vitro diagnostic (IVDs) manufacturers has found access to notified bodies has improved. However, uncertainty around costs, timelines and predictability are still creating problems for the medtech industry.

MedTech Europe surveyed manufacturers last year, revealing an increase in the proportion of companies that had agreements with notified bodies. The trade group said it was “concerning” that some medical device manufacturers still lacked agreements at the time of the survey, though, and found the variability of costs across notified bodies is challenging manufacturers.

“By the end of a five-year certification cycle, IVD manufacturers will spend 70% more on maintenance and re-certification, while MD manufacturers face a 50% increase,” MedTech Europe said. In the first year, personnel costs account for 90% of spending on the regulations. Notified body fees makeup 7% of the outlay.

The survey found more than half of the conformity assessment time is spent outside the review phase. MedTech Europe said, “Streamlining pre-review and certificate issuance could reduce total assessment time.” The feedback comes as the European Commission is collecting industry input on whether the rules on devices and diagnostics are effective, efficient and proportionate.

Press Release

Commission calls for medtech supply chain assessments to mitigate cybersecurity risks

The European Commission has called for a “coordinated security risk assessment” to evaluate technical and strategic threats related to medical device supply chains.

Officials called for the Network and Information Systems Cooperation Group to perform the work in an action plan on the cybersecurity of hospitals and healthcare providers. The action plan looks at ways to protect the health sector from cyberattacks. While the advice covers hospitals and healthcare providers, the identification of devices as cybersecurity weak links means the report has implications for medtech.

The Commission envisages the Medical Device Coordination Group contributing to the risk assessment as needed. Officials noted the cybersecurity requirements of the medtech regulations, adding that the “ongoing evaluation” of the legislation “is examining the potential for greater coherence and synergies between these frameworks in order to guarantee simplification and state-of-the-art cybersecurity.”

The Commission said that healthcare organizations should use the risk assessment findings to inform reviews of their supply chain cybersecurity practices. The findings could also support the development of new procurement guidelines that build on the good practices for security in hospitals text that the European Union released in 2020.

Press Release

MHRA sets out details of upcoming real-world evidence scientific dialogue pilot program

MHRA has provided information about a UK real-world evidence (RWE) scientific dialogue pilot program that will start accepting applications of interest next month.

The pilot is intended to “help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations,” MHRA said, and support “robust decision-making across the entire lifecycle of products.”

Participants will gain access to “a closed-door, confidential virtual meeting” where they can talk to MHRA about commercially sensitive topics, as well as to a “pre-competitive, ‘safe harbour’, workshop” set up by the agency and the National Institute for Health and Care Excellence. MHRA said the workshop will promote “open dialogue and shared learning about RWE topics.”

MHRA has excluded medical devices and proposals involving drugs under active regulatory procedures from the pilot. The initiative is open to medicinal product activities with a specific focus on RWE. MHRA will prioritize proposals that target public health challenges and areas of significant unmet clinical need.

The agency will accept applications of interest from 10 February to 4 April. Virtual meetings are planned for May and July and the workshop is scheduled for June. MHRA will finalize the format of the workshop in consultation with participating parties.

MHRA Report

Other news:

EMA has revised its rules on the handling of competing interests of members and experts on its scientific committees and of members of its management board. The policies, which will take effect in May, reflect court rules that required EMA to adjust its approach. Respondents to a consultation on the scientific committee policy raised concerns that changes would restrict EMA’s access to expertise. EMA Notice

New rules on health technology assessment in the EU took effect on 12 January, although they initially only apply to new active substances to treat cancer and all advanced therapy medicinal products. The first request period for joint clinical assessments will open in February. Officials have updated the rolling plan for implementing the remaining key activities. Press Release, Rolling Plan

MedTech Europe has published a paper on the need for “comprehensive and adaptive evaluation frameworks” for digital medical devices. Reflection Paper

Euro Roundup: MHRA shares guidance on incoming changes to medtech postmarket surveillance

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