Until now, Market Authorization Holders could bring their integral combination products to the European market by using the pharmaceutical approval process – the products could be approved as part of the pharmaceutical product. With the new EU Medical Device Regulation (EU MDR) 2017/745 since May 2021, especially the requirements for integral combination products have increased.
In many cases, the Notified Body must be involved now if the medical device component itself is not a CE-marked medical device. The confirmation of the drug agency by itself is therefore no longer sufficient. The Notified Body checks the General Safety and Performance Requirements (GSPR), which must be fulfilled according to EU MDR Annex I, and issues the opinion on the conformity of the medical device component.
Due to the new GSPRs that have to be proven, the Market Authorization Holder and those who want to become one, are confronted with new challenges such as risk management according to ISO 14971:2019, the update of the technical documentation and more.
The expert presentation provides insights for each individual as to whether the MDR introduction also affect their own combination product and which possibilities exist to meet the new requirements.
Maren Wiese, Senior Consultant at gempex, clarifies as Medical Devices Expert at the COMPAMED in the Supplier Forum. Practically versed in quality management, auditing, quality assurance, and vigilance from responsible positions in the medical device industry, she has been active in medical device consulting for years, including in the field of combination products.
With her presentation "Combination Products - Medical Device Regulations for Market Authorization Holders", Maren Wiese will show market authorization holders of combination products which medical device regulations have to be taken into account in order to be accepted by the regulatory authorities on November 15, 2021 at 3:00 p.m.
The trade fair COMPAMED will take place parallel to the MEDICA medical trade fair from November 15 - 18 at the Düsseldorf Exhibition Center in Halls 13 and 14 and presents itself as an information and communication platform for:
- Technical buyers
- Heads of research and development departments
- Engineers and technicians from R&D and from production
- Production managers and designers
- Medical technology exhibitors at MEDICA
- Packaging specialists and process engineers
- Quality assurance and quality control managers
- Qualification and validation specialists
What else might be of interest to you on this topic:
In her article Eyes open for combination products, published in DeviceMed April 2021, Maren Wiese explains the impact of the EU Medical Device Regulation (EU MDR) 2017/745 on the approval process for combination products (German language).
In addition, gempex has compiled an InfoSheet on the topic of "Risk Management for Combination Products" explaining the main changed requirements requested by the EU MDR. The pdf can be downloaded directly here.
On this website you will find more information about compliance consulting for combination products.