Medical Device Regulation: Key Changes and what it means for Combination Products

A Pharmafocus webinar

On Thursday 4th June 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, Dr Tina Amini, Medical Device Division Director, NDA Group will guide you through the key points to consider in your efforts to become Medical device regulation (MDR) compliant and focus on the implementation of MDR Article 117.

The EU MDR continues to provide challenges for the medical device industry and pharma/biotech companies.

Medical device manufacturers must meet new obligations under the new regulations such as correct classification of devices, general safety and performance requirements, UDI systems, new vigilance reporting timescales, sufficient clinical evidence, a person responsible for regulatory compliance and other obligations as per Article 10 of MDR. To date, only a few devices have been certified under the new MDR.

The regulation also impacts pharma/biotech companies. MDR Article 117 amends the medicinal product directive (Directive 2001/83/EC) and requires that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body depending on the device classification.

Manufacturers who are developing integral DDCs need to consider this change in requirements and assess the impact on their development programmes. Companies must identify a notified body to provide an opinion on the conformity of the device to the MDR. For some, this is a new and unknown process with no defined timelines.

Topics covered will include:

  • Medical Device Regulation key changes
  • Possible bottlenecks
  • The requirements of Article 117 as it applies to new drug/device combination marketing applications and variations
  • Notified Body selection and interaction process
  • Submission requirements to facilitate Notified Body review and the latest guidance with respect to Notified Body Opinions

To learn more about NDA’s Medical Device division and services click here


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About the Speaker

Dr Tina Amini, a pharmacist with a PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group.

She has over 30 years’ experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor.

Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry in a variety of disciplines.