Amsterdam: The European Medicines Agency (EMA) has updated its advice for developers of combinations of medicinal products and medical devices.
MDR and IVDR imposed new requirements on companies that seek and obtain authorization of products that combine drugs and medical devices. The regulations also affect the notified bodies that assess the conformity of medical devices.
Exactly what is required of industry and notified bodies depends on the product. The regulations for devices with integral drug products, such as pre-filled syringes and patches for transdermal drug delivery, differ from drug-eluting stents and other devices that have ancillary medicinal substances. Companion diagnostics have their own set of rules.
The EMA published a question and answer document in 2019 to help all parties affected by MDR and IVDR adapt to the regulations and has now revised the document. In the latest update, the EMA added six questions and revised answers to most of the existing questions.
One new question covers how to obtain advice about the classification of drug-device combinations, particularly products that are on the borderline between MDR and pharmaceutical legislation. The EMA’s Innovative Task Force can share scientific views to facilitate development, the agency said, but only national competent authorities can provide formal advice.
The EMA has also added a question on the consultation procedure for companion diagnostics. The agency used the update to explain when a notified body must seek the EMA’s scientific opinion on the suitability of a companion diagnostic to a medicinal product. The EMA linked out to other documents on companion diagnostics in its response.
Some of the changes to existing questions and answers are limited to tweaks to the wording, but the EMA has also made more significant revisions. A response to a question about drug-device combinations authorized under the old directive now features a paragraph that explains the need to assess and provide a justification for whether a change has no significant impact on a product’s safety or performance.
The EMA has also expanded its response to another question about changes to authorized products. The expanded response explains when a new or revised notified body opinion is needed for the device part of a combination.
