On 13 October 2023, the Medtech & Pharma Platform (MPP) Association submitted a statement to the European Commission on its proposals for the revision of the EU general pharmaceuticals legislation. The MPP Association welcomes the proposals’ objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness.
The MPP advocates for a better alignment of the text of the proposals with the applicable medical devices legislation in the EU, on various aspects including definitions, in order to avoid divergences and legal uncertainties. Additionally, the MPP calls for clarifications on several points which are not sufficiently specified or may lead to conflicting interpretations. This includes the information supporting medical device/IVD compliance with the MDRs/IVDRs requirements which can be requested by the competent authorities as part of marketing authorization and variation applications or a pediatric investigation plan, the assessment of the risks linked to the medical device/IVD or the labelling and information requirements of combined products. The MPP recommends incorporating measures in the legislation that would allow Notified Bodies to provide an opinion on medical device technology platforms which are part of drug device combinations covered by the EU medicinal product legislation. This will prevent work duplication in the review of the information relating to the platform, as the notified body opinion on the platform would be considered when assessing specific combinations. Furthermore, proposed amendments aim to ensure that Notified Body expertise is considered during the scientific advice procedure for medicinal products used with a medical device. Additionally, the role of medical device expert panels and the scope of their intervention should be clearly defined in the proposals. We recommend amending the proposals to clarify that products intended for the sterilization of packaging, specifically ethylene oxide, are covered by the medicinal product legislation, provided they are manufactured on a site holding a manufacturing authorization, in line with the position communicated by the European Commission in the first half of 2023.
The MPP continuously seeks dialogue with relevant stakeholders to create an appropriate framework for combined products that fosters innovation, reduces time to market, and addresses patients needs. We thank you for considering our position and the proposals outlined in the attached document.
You can download our input here.