MedDev Day

The MDR has been applicable since May 2021.
Over the last years, industry and regulators have made significant efforts to adapt to the Regulation.
Recent improvements are, among others, the number of notified bodies designated under MDR, the preparation and voluntary use of EUDAMED modules, the significant increase of MDCG Guidance documents and the activities and opinions of expert panels for certain high-risk devices.
This is in line with the overall goal of the Regulation to increase the attractiveness of the EU market as well as the quality, safety and performance of devices for patients and consumers.

Despite positive developments, the overall capacity of the regulatory system still needs to be improved.
While manufacturers have concerns about meeting the requirements of the MDR by the end of the transition, the system's capacity needs to be increased to process the number of certificates that need to move from MDD/AIMDD to MDR.

In early 2023, a legislative proposal by the European Commission was published that aims to extend the transition period and validity of certificates under certain conditions to 2027 for high-risk and to 2028 for medium and low-risk devices. This legal proposal is accompanied by supporting non-legislative measures that aim to support notified body capacities, back the industry and ensure the uninterrupted availability of medical devices.

In this dynamic context, the 5th edition of MedDev Day will give you a chance to rest and understand where the regulation stands. The conference will give insight into recent developments impacting MedTech industry and bring representatives from competent authorities, notified bodies and industry to share strategies, best practice solutions and recommendations.

A pre-conference workshop will precede the MedDev Day on Writing the Summary of Safety and Clinical Performance (SSCP): from good to excellent!

The conference will highlight the regulators’ perspective on the MDR state of play, non-legislative support measures, and conditions to be met by manufacturers to benefit from transition provisions and extended certificates. Also, practical insights on how to apply for temporary bridging measures under Article 97 will be conferred.

The MedDev Day will further reveal developments in clinical evaluation consultation opinions and state of play for the voluntary advice to manufacturers on clinical development strategy and clinical investigations. Participants will finally have the opportunity to understand the next steps and an outlook on the future of the regulatory system beyond 2024.

The Scientific Committee:

Scientific Board
Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH
Sabina Hoekstra-van den Bosch - Regulatory Strategy Principal at TÜV SÜD
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical

MedDev Day Scientific Coordinator
Laura C Collada Ali - Senior Medical Writer & Scientific Manager at LS Academy

Who should attend?
The conference is designed for professionals in the field of Medical Devices, devoted to departments such as:

• Clinical Operations
• Product Managers
• Regulatory Affairs
• Quality Assurance/Control
• Risk Management
• Medical Device Engineering
• Device Vigilance
• R&D
• Medical Affairs
• Medical Writing

from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations., competent authorities, EU Commission and Surveillance authorities.