The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first European Medicines Agency (EMA) guidance related to the new EU medical device regulation (MDR).
The guidance, published on Thursday, is part of the agency’s work to aid the transition for industry to comply with increased requirements under MDR. It was jointly developed in a Q&A format by EMA and the Coordination Group for Mutual Recognition and Decentralized Procedures – Human in collaboration with the European Commission (EC). EMA executive director Guido Rasi noted the guidance comes at a time when regulators are facing new challenges around “the ever-increasing pace of innovation and the blurring of traditional boundaries between medicines and devices.”
From the 26 May 2020 compliance deadline, MDR will require a marketing dossier for a medicinal product with an integral medical device to include the results of the NB-issued assessment of conformity or relevant certificate. This requirement will be implemented under Article 117 of the regulation. Its implications for medicinal products are further detailed in the answer to the first of seven questions.
The guideline describes three conditions that would render a medicinal product subject to the new requirement. These conditions relate to the device and the medicinal product forming a single integral product that is exclusively intended to be used in the given combination and is not reusable.
“Approximately one in four centrally authorized medicines includes a medical device component, and the majority of these involve an integral device,” EMA noted
. “This includes for example pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers.”
The impact Article 117 will have on new marketing authorization applications is explained under the third question, which includes a table that summarizes MDR-related changes for applications of medical products with integral medical devices. A declaration of conformity and/or EU NB certificate will be expected for such applications as of 26 May 2020 so that the manufacturer can affix CE marking to the device. In lieu of this documentation, applicants must otherwise provide a conformity opinion from an NB if the device component is classified as a sterile class I, measuring class I, class IIa, class IIb or class III.
Answers four through six explain that the new requirement will only apply to applications covered by the guidance
that were submitted from 26 May 2020, rather than prior to this date, and EMA’s recommendation for applicants to submit the required documentation as part of the initial application. The last answer provides a brief description of two cases in which a new or updated EU certificate, declaration of conformity or NB opinion would be needed for a change to the device component.
The upcoming series of EMA guidance is intended to aid in preparations
and transitions for compliance with MDR and the new EU in vitro
diagnostic regulation (IVDR). MDR and IVDR come into full effect in May 2020 and 2022, respectively. The EC recently updated
the MDR/IVDR rolling plan on the implementing acts and actions needed prior to the enactment of the two regulations. Revisions noted an increase in the number of applications receiving NB designation against MDR and IVDR, totaling 42 compared to 33 applications last October. Yet NB availability
and readiness remain
concerns for industry and a no-deal Brexit is expected to exacerbate the issue. BSI UK became
the first MDR-designated NB just last month.
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe