Welsh Government

Medical devices: research practice and the new regulations

Course Title:                       Medical Devices: Research practice and the new regulations (MDR)

Facilitator:                          Dr Pete Wall

 

Course Outline:

The new European Medical Device Regulation (MDR) replaces the existing Medical Device Directive (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC).

The MDR enters into force in May 2017 and this will trigger the start of a three year transition period for manufacturers to meet the new requirements.

The new MDR brings significant changes to the areas of clinical investigation and clinical evaluation of medical devices. These changes place increased requirements on manufacturers and developers of medical devices, both in terms of the clinical data required to support market applications and the scrutiny that will be applied to the review of regulatory submissions.

 This full day course will explore:

- the changes in the key areas of clinical investigation and clinical evaluation;

- the implications of these changes for medical device manufacturers and the way that clinical investigations and clinical evaluation will have to be undertaken.

The format of the day will include presentations and discussion.

Please note a certificate of attendance will only be issued if delegates complete all elements of the training.

Times will be confirmed on receipt of the registration form


Following the training, participants will: 

  • Have an awareness of the new European regulatory requirements associated with clinical investigations and clinical evaluation of medical devices
  • Have an understanding of how the MDR will affect clinical investigations and clinical evaluation of medical devices

Search for available course dates here