UK MHRA Post-Market Surveillance (PMS) Legislation on Its Way: Newly Laid in Parliament
23 October 2024
Newly Published: Q&A on Obligation to Inform of Device Interruption or Discontinuation
30 October 2024A lot of information is circulating about the EU Parliament vote to adopt legislative changes to the MDR/IVDR. But what does this actually mean?
Background
The MDR/IVDR implementation has been fraught with issues:
- Lack of Notified Body resources, and therefore long lead times to market
- Increased fees, which were prohibitive for SMEs
- EUDAMED is still not live; meanwhile the MDR’s original date of application was May 26, 2020
- Delays in provision of guidance documents, harmonized standards, common specifications
The MDR and IVDR have each been postponed several times. Brexit and the pandemic occurring in the meantime certainly did not help. Due to this, there are legitimate concerns about a possible shortage of medical devices in Europe:
- That some manufacturers will decide not to transition some, or even any, of their legacy devices to the MDR/IVDR.
- Europe is losing global competitiveness, and companies will choose to bypass Europe in their initial market entry plans, due to the increased costs and time to market.
The general industry consensus has been that, while well intended (see: PIP scandal), the regulations overcorrected. As a result, the EU Commission has been assessing if the MDR/IVDR are “effective, efficient, and proportionate”.
EU Parliament Actions
Parliament added MDR/IVDR reform as a topic to its October plenary sessions.
Oct 9, 2024 Debate
A verbatim transcript of the European Parliament debate is available: HERE
A few felt the Regulations were fine as they stand today; however, the majority felt at least some reform was appropriate.
The main disagreements were primarily around 1) how urgent or extensive these revisions should be, and 2) whether only specific aspects (like compliance deadlines) should be adjusted, or if a broader reform of the MDR is required to address other structural issues.
The discussion closed, noting that voting would occur in the next session.
Oct 23, 2024 Voting Results
The voting resulted in the joint motion for resolution RC-B10-0123/2024 to be adopted. It passed with 545 in favor, 80 against, and 15 abstentions.
Overview of Resolution
The adopted text is available: HERE
Below are some highlighted items from the text:
“Calls on the Commission to propose, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible;”
“Advocates the creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies, thus creating predictability and certainty for manufacturers regarding the market access procedure and its duration within the EU;”
“Calls for transparency in notified bodies’ fees and fee structures, to allow economic operators to compare notified bodies and make informed choices, ensuring that fees remain a fair compensation for the public service provided;”
“Stresses the need to eliminate the unnecessary re-certification of products, and underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification of the product; stresses the need to harmonise such provisions and ensure consistency across the EU; calls for cooperation between the competent authorities and advisory bodies responsible for other regulatory frameworks, and stresses the need for products to be classified correctly and consistently;”
“Strongly calls on the Commission to consider fast-track and prioritisation pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies;”
Industry Response
Since the debates and vote, there have been immediate responses issued, e.g., the below and industry groups like MedTech Europe.
Statement from HMA
The HMA Core Group for Medical Devices is a Working Group within the Heads of Medicines Agencies (HMA) network, and they focus on medical device regulation in the EU.
They published a letter in response to the above, available: HERE
The gist of the letter is to caution against taking drastic action, i.e., the members of Parliament who called for a proposal to be presented within 100 days of the next Commission taking office on November 1, 2024.
The HMA Core Group for Medical Devices expressed concern that this could create other unintended problems. And instead, to take sufficient time to perform an analysis on the level of changes needed, and adequate timing to implement revisions to the legislation.
“….reflecting on the experience of the implementation of the two current Regulations and the many challenges encountered we have to avoid a situation where this is further complicated through the potential introduction of policy or legislation that has been rapidly expedited and not properly considered.”
Team Notified Body Press Release
Team Notified Body (NB) also weighed in: HERE
They too are in favor of some reform, noting:
- Manufacturer delays in providing documentation, is delaying the certification process, which in turn may create bottlenecks as the 2027 and 2028 deadlines near.
- In favor of reviewing the data once during a life cycle process, and eliminating the need to review and report on the same data as part of different processes, such as technical documentation, PSUR, PMC(P)F, CEAR/PEAR assessments.
- To use common specifications more broadly, to specify the types and levels of clinical evidence required for various types of devices, including well-established technologies.
- Help SMEs with financial support to go through the NB certification process.
- Introduce fast-track pathways for breakthrough and life-saving products.
What does all this actually mean?
Resolution 2024/2849(RSP), ‘Resolution on the urgent need to revise the Medical Devices Regulation’, is Parliament’s “call to action”. It is not legislative change in and of itself. For any actual reforms to the MDR/IVDR, the Commission would need to propose formal amendments or new regulations, which would then go through the full legislative process, including approval by both the Council of the European Union and the European Parliament.
Instead, it is formal political pressure on the European Commission to prioritize reform and act more swiftly.
The European government is already well aware of the concerns, of course. And have introduced various action, e.g., the Commission’s Have your say initiative, to if evaluate the MDR/IVDR:
- are effective, efficient and proportionate
- meet current and emerging needs
- align with other actions
- have EU added value
This is all part of a larger ongoing discussion on the impact the MDR/IVDR has had on the European market, i.e., what remediations are necessary to ease market access, while still ensuring patient safety? But certainly, EU Parliament is putting their political weight behind MDR/IVDR reevaluation and reform.
