New whitepaper from Maetrics highlights regulatory updates and foreseeable challenges facing manufacturers of combination products and companion diagnostics
July 2019 – Medilink EM Member Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper on the adaptations and additions to the EU Medical Device Regulation (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. Manufacturers have until 26th May 2020 (and until 26th May 2022 for companion diagnostics) to comply or risk losing European market access.
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.
Some key take-away points Maetrics covers in this whitepaper are:
- Pharmaceutical manufacturers are now subject to regulatory oversight for both the device and medicinal parts of their combination products, and must liaise with Notified Bodies for the ancillary device component;
- For device-regulated products, businesses must ensure they allow time for the consultation between Notified Bodies and a national Competent Authority or the European Medicines Agency (EMA) to assess the ancillary drug function;
- Regulation of companion diagnostics falls under the EU IVDR and requires the in vitro diagnostic device to be co-developed with the target medicine and will also require the IVD Notified Body to liaise with a medicinal Competent Authority;
- EU IVDR requirements place greater regulatory scrutiny on pharmaceutical companies producing companion diagnostics, as well as necessitating greater engagement from Notified Bodies if it is the intention of the pharma company to develop the companion diagnostic themselves;
- Notified Bodies are slow in receiving their own designation under the two new regulations, causing reduced capacity and creating a backlog of companies queuing to apply for conformity assessments.
The full whitepaper is available for download here.
Elizma Parry, Director Global Clinical Practice at Maetrics, comments: “The main challenge for pharmaceutical companies is the unprecedented change in the EU MDR requiring them to liaise with Notified Bodies for device components. Add to that the lack of Notified Bodies designated under EU MDR, pharmaceutical companies could find themselves seriously behind when it comes to ensuring regulatory compliance for combination products.
“We want manufacturers of combination products to understand the changes and challenges facing them and the time limitations involved so they engage as soon as possible with their Notified Bodies. There are significant challenges to overcome, and many companies may not have the right expertise available in-house to work through the compliance process. With qualified professionals in high demand, I cannot stress enough the importance for manufacturers and pharmaceutical companies to address the EU MDR compliance head-on and immediately.”