Reflection paper

Basel, 17 December 2019

The Medtech & Pharma Platform (MPP) is proud to publish the joint industry paper “Reflection paper on regulatory uncertainties for co-packaged and cross-labelled drug-device combinations under the new Medical Devices Regulation”. The preparation of the paper was led by the MPP in collaboration with The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe (MfE).

The goal of this paper is to inform stakeholders in the field, including regulators, to encourage dialogue and stimulate clarification, thereby supporting understanding of the requirements in these areas and the effective and orderly implementation of the MDR.

The Reflection Paper is the culmination of feedback provided by the members from the three authoring Associations on regulatory uncertainties related to non-integral combination products in the current Medical Devices Regulation (MDR).

The paper identifies these areas of uncertainty, details how these areas are presently understood by the contributing Associations and their members in the absence of further guidance, and addresses the potential impacts on stakeholders associated with the medtech and pharma sectors. Specifically, the paper addresses, among other aspects, Art. 16, Art. 22, Art 27, Art 31, Art. 85, Art 86, and changes to the responsibilities of Notified Bodies under the MDR.