The European Medicines Agency (EMA) released in June a draft guideline on the quality requirements for medical devices in human medicines which include a medical device, known as drug-device combinations, for public consultation.
The guideline addresses the new obligations set out in the EU Regulation on medical devices, in particular the requirements about marketing authorisation applications. It is intended that this guideline will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety.
IDF Europe contributed to this public consultation, identifying the three core recommendations to deliver the most significant change in the regulatory system over the next five years. These are:
- Promote the availability and uptake of biosimilars in healthcare systems
- Contribute to the HTA’s preparedness and downstream decision-making for innovative medicines
- Develop the regulatory framework for emerging digital clinical data generation
In the consultation, IDF Europe also outlined the main gaps in the strategy:
– Restoring the trust between Health Technology Assesment companies and the rest of the society
– Taking into account the experiences of health technologies’ existing users
– Improving the systems of pharmacovigilance and materiovigilance
– Providing the data needed to adjust the pricing according to the results of real-life studies
Please contact our Policy and Project officer Winne Ko ([email protected]) for more information on IDF Europe’s full response to the EMA consultation on medical devices.
Read our Position Paper on Biosimilars
Read our joint statement on HTA
Learn more on the new EU Medical Devices Regulation here
