The European Medicines Agency released a new question and answers document on its Medical Devices Regulation and In Vitro Diagnostic Regulation in an attempt to answer mounting questions from industry.
The agency released a similar document early in the year, but the new Q&A provides more details on how the new regulations will be implemented starting May 26, 2020 for devices and May 26, 2022 for IVDs.
The new Q&A adds information on how combination products will be regulated, and which division will review certain combination products, as well as the process for selecting notified bodies, how the new regulations will affect mutual recognition procedures and timelines for changes to devices.
For combination products, the EMA follows similar rules as the FDA when it comes to which division will review the device or drug. For example, if the action of the device is primary, then the combination product will be regulated as a medical device and must be CE marked. If the drug is primary, then the product is regulated as a medicinal product.
Companies are “free to choose the notified body they engage with,” the EMA said, noting that the only requirement is that the notified body must be designated to carry out conformity assessment procedures for the device type for which a certification is sought.
If a combination product forms a single integral product that is not reusable, the product is governed by the Medicinal Product Directive 2001/83/EC. Examples of integral products are pre-filled syringes, pre-filled pens, nebulizers re-charged with a specific drug, patches for transdermal drug delivery and pre-filled inhalers.
Article 117 of the MDR amended directive 2001/83/EC. The change means that, for a device component with CE marking, devicemakers must include a declaration of conformity or the EU notified body certificate with their marketing authorization applications. In some cases, an opinion from a notified body on the conformity of the device part may be submitted, the agency said.
The EMA clarified that Article 117 will not apply to marketing authorization applications submitted before May 26, 2020.
Devicemakers will need to provide a new declaration of conformity when substantial changes are made to a medical device component that affect performance and safety characteristics.
Mutual Recognition Procedures
The mutual recognition procedure, in which an authorization of a device in one EU member state is recognized by another member state, and the repeat use procedure — the use of a mutual recognition procedure for recognition of a marketing authorization by another member state — are new applications for marketing authorization, and devicemakers will need to meet all MDR requirements if an application is submitted after May 26, 2020, including Article 117 for integral devices.
UDI requirements are not applicable to integral combination products if the product is regulated as a medicinal product, when the device component is ancillary.
For integral devices with a CE Mark, the UDI may be assigned to the device itself. However, the UDI should not appear on the labeling or outer package of the medicinal product, the EMA said.
Read the EMA Q&A here: www.fdanews.com/11-07-19-EMA.pdf.