15/16 February 2022
With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 26, 2021, new requirements have been/will be imposed on combination products (products containing a medicinal product and a medical device) with regard to their medical device component. There is a question-and-answer document (Q&A) from the European Medicines Agency (EMA) that has been updated to address current issues.
Target groups of the Q&A are applicants, marketing authorization holders of medicinal products and notified bodies (NB) in connection with medical devices and/or in vitro diagnostics. The Q&A document is 13 pages long and divided into 4 chapters:
1. Combination of Drugs and Medical Devices
2. Drug-Device Combinations
3. Drugs containing a Medical Device in the secondary packaging ("co-packed")
4. Consultation Procedures regarding ancillary action in a Medical Device
Chapter 1 addresses the respective regulations that apply to products containing a drug as well as a medical device. It also explains how to select notified bodies (NBs) for a drug-medical device combination. The NANDO website provides assistance in this regard.
Chapter 2 clarifies for "Drug-Device Combinations" (DDC), among other things, when a medical device forms an integral product together with a medicinal product. In several subchapters, questions regarding §117 of the MDR are then dealt with in great detail in a question-and-answer format. Section 117 MDR deals with the notified body opinion if medicinal products with an integral medical device are also to be marketed as medicinal products. One question (and answer) addresses the Unique Device Identifier (UDI) labeling system of medicinal products that contain a medical device as an integral component.
Chapter 3 answers questions about medicinal products that are accompanied by a medical device in light of the MDR. It deals with the labeling of the medical device, certificates of conformity, and any necessary up-classification of the medical device in accordance with the MDR.
Chapter 4 consists of only one question as a subchapter. The question (and answer) deals with the necessary consultation procedure for a medicinal product with an ancillary effect, which was previously covered by the (old) Medical Device Directive. What needs to be done here in relation to the MDR? A table provides guidance on how to proceed in this regard when a change request (variation) is pending.
You can find the complete question and answer document on the EMA website.