Euro Roundup: Working group posts MDR, IVDR manual on borderline devices

RoundupsRoundups | 15 September 2022 | By

The Borderline and Classification Working Group (BCWG) has created a manual for determining whether a product is classed as a medical device under the new regulations. BCWG developed the document as part of an attempt to prevent member states from having different interpretations of the legislation.
The manual records the agreements reached by members of BCWG covering the qualification of products at the borderline of different categories, such as medical devices and in vitro diagnostics (IVDs), and rules for classifying medical devices and IVDs.
In the qualification sections, BCWG discusses the characteristics of borderline products and the outcome of assessing whether they are a medical device. For example, the manual cites nasal sprays with antibodies for COVID-19 as an intervention that exists at the borderline between medical devices and medicinal products. The product is not a medical device because of its mechanism of action.
The manual, the first version of which was published this month, remains a work in progress. BCWG needs to complete some sections, explaining that they will be populated when cases are finalized under the Helsinki Procedure. The procedure was first agreed to in 2002 to allow competent authorities to discuss borderline and classification issues concerning medical devices.
Commission Notice
EU Parliament health committee ‘deplores’ reduction in EMA 2023 budget in draft proposal
The European Parliament’s health committee has spoken out against the draft budget for 2023. As part of its review of spending plans for next year, the committee said it “deplores the budgetary reduction” at the European Medicines Agency (EMA).
In 2022, the EU is set to provide €55.2 million ($55.2 million) to EMA. The forecast EU contribution for 2023 is €49.4 million, a 10% decrease at a time when the agency is adapting to its expanded remit. Emer Cooke, EMA executive director, raised concerns about the situation late last year, noting that activity at the agency had risen 43% over a seven-year period in which its budget shrank by 10%.
Under the proposed budget, EMA’s headcount is forecast to remain unchanged at 915, with a 4% rise in other revenues offsetting the fall in EU funding. The total funding to EMA is set to rise slightly, despite the EU planning to reduce its contribution.
Even so, the Committee on the Environment, Public Health and Food Safety (ENVI), which has a history of calling for more support for EMA, came out against the budget. ENVI’s opinion addresses the need for EMA to be adequately funded and staffed, while also raising similar concerns about the spending plan for the European Centre for Disease Prevention and Control (ECDC).
The proposed reductions to the EMA and ECDC budgets are part of a broader row over spending plans for 2023, which has seen the Council’s proposal to cut commitments by €1.6 billion branded as “far from prudent or realistic.”
ENVI Opinion, Draft Budget
Pfizer wins approval for Omicron BA.4-5 version of Comirnaty in EU
Pfizer has won EU approval for the bivalent version of Comirnaty, its COVID-19 vaccine. The vaccine addresses both wild-type SARS-CoV-2 and its Omicron BA.4 and BA.5 subvariants.
Early last month, EMA looked set to wait for clinical data on BA.4-5 vaccines before recommending them for authorization, setting it apart from its counterpart in the US that sought to make the shots available as quickly as possible. Evidence of a shift in EMA’s thinking emerged at the start of September when the European Commission said a BA.4-5 vaccine could receive accelerated authorization in the fall.
The Commission’s prediction quickly came true. Ten days later, EMA’s Committee for Medicinal Products for Human Use recommended authorizing a bivalent version of Pfizer’s Comirnaty. The Commission then quickly authorized the vaccine.
EMA recommended the vaccine for authorization on the strength of clinical data on the bivalent form of Comirnaty that is designed to protect against BA.1, plus data on the quality and manufacturing process of the BA.4-5 vaccine. Based on the data, EMA expects the bivalent vaccine to be more effective at triggering an immune response against its targeted subvariants. ECDC lists BA.5 as dominant in the EU. EMA will review results from ongoing clinical trials of the BA.4-5 vaccine as they become available.
EMA Notice
MHRA introduces new conflicts of interest code for independent advisors
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new code of practice governing the conflicts of interest of members of its scientific advisory committees.
Acting on the recommendation of the Independent Medicines and Medical Devices Safety Review, MHRA held a consultation about the proposed new code earlier this year. The consultation, which received 217 responses, found broad support for the idea of introducing a single code of practice covering all MHRA advisory committees, with 86% of respondents identifying that as their preferred option.
MHRA has responded to the feedback by publishing a code of practice that sets out the rules and process for identifying and declaring personal and non-personal interests that are potentially relevant to the work of a committee, as well as how those interests will be managed. Individuals involved with the committees and their supporting groups are responsible for identifying and declaring interests.
People who fail to comply with the code may face disciplinary action such as written or verbal warnings, a direction to relinquish conflicting interests, restricted involvement in the committee or the termination of their appointment. If needed, MHRA will assess the impact of a conflict on the integrity of the scientific review.
MHRA Notice
MDCG updates advice on when IVDR notified bodies need to consult the expert panel
The Medical Device Coordination Group (MDCG) has updated its guidance on when notified bodies need to consult the expert panel about class D in vitro diagnostics (IVDs).
Under the IVD Regulation, notified bodies need to consult the expert panel on the manufacturer’s performance and evaluation report if there is a lack of common specifications for the class D device and it is the first certification for that type of device. MDCG provided guidance to help notified bodies interpret the regulation last year.
The update adds six notes to a section about the meaning of “the first certification for that type of device” in IVDR. The notes provide additional information about handling automated and semi-automated devices, devices that use different technologies for the same intended purpose, multiplex and single analyte IVDs and more.
MDCG Guidance
Other News:
Trade group EFPIA has worked with technology provider GSI to make electronic product information leaflets available to Ukrainians living in Poland. The initiative will enable people displaced by the war with Russia to obtain product information in their own language. EFPIA sees the initiative as reducing the risk that medicines will be misused due to language barriers. EFPIA Notice


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