Integral Drug-Device Combinations and Medical Device Regulation Article 117: The European Medicines Agency...

Area of Science:

• Regulatory Science
• Pharmaceutical Medicine
• Medical Device Regulation

Background:

• Integral drug-device combinations (iDDCs) are regulated under EU medicinal product laws, requiring adherence to medical device framework requirements.
• The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) introduced significant changes, particularly Article 117.
• Previously, the European Medicines Agency (EMA) and National Competent Authorities (NCAs) evaluated both the medicinal product and the device component.

Purpose of the Study:

• To outline the European Medicines Agency's (EMA) perspective on the implementation challenges of Article 117 of the MDR.
• To identify opportunities for addressing the complexities arising from the new regulatory framework for iDDCs.
• To enhance understanding and facilitate smoother regulatory processes for iDDCs.

Main Methods:

• Analysis of the regulatory shift introduced by Article 117 of the MDR concerning iDDC assessment.
• Review of the European Medicines Agency's (EMA) guidance and engagement activities to support stakeholders.
• Presentation of EMA's viewpoint on challenges and potential solutions for Article 117 implementation.

Main Results:

• Article 117 of the MDR designates notified bodies as responsible for assessing the integral medical device component against stringent General Safety and Performance Requirements (GSPRs).
• This shift has created regulatory complexities and challenges for the pharmaceutical industry, EMA, EU NCAs, and notified bodies.
• EMA has actively engaged in providing guidance and facilitating discussions to support implementation and mutual understanding.

Conclusions:

• The implementation of Article 117 necessitates a collaborative approach among all stakeholders to navigate the complexities of iDDC regulation.
• Addressing the identified challenges is crucial for strengthening regulatory oversight and increasing confidence in the iDDC regulatory system.
• Continued dialogue and shared experience are vital for the successful lifecycle management of integral drug-device combinations.