Manufacturers of drug device combination products have until 26th May 2020 (and until 26th May 2022 for companion diagnostics) to comply with the the EU Medical Device Regulation (MDR) or risk losing European market access.
Maetrics’ newest whitepaper details the adaptations and additions MDR pertaining to drug device combination products. The whitepaper looks closely at the changes in the regulation and highlights what manufacturers need to know to keep their products on the market. The whitepaper also looks at new components of the EU In Vitro Diagnostic Regulation (IVDR) affecting companion diagnostics.
Combination products can be composed of any amalgamation of an ancillary drug, a device or biologically active product. The EU MDR will impact medical devices that are used to administer medicinal products, causing pharmaceutical manufacturers to seek unprecedented regulatory oversight for both the device and medicinal components of the product. Manufacturers must be prepared to liaise with a Notified Body for compliance instead of relying solely (as previously required) on the national Competent Authority for product authorisation.
This new whitepaper has been published to increase awareness among combination product manufacturers about the changes and what the regulatory landscape holds for them in the coming months.