Changes to the medical device regulations and impact on the dental world

15:15 - 16:00

AIMS

o    Overview of the MHRA and its role in the regulation of medical devices.

o    Outline of the regulatory system for medical devices and key messages from the Regulation for Medical Devices (MDR) (https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr).

o    Class I and custom-made devices and Annex XVI products

o    Impact of the MDR on Health institutions and healthcare.

o    The role of adverse incident reporting in improving protection of public health and patient safety.

Participants maybe interested in MHRA’s introductory interactive guide to the new EU Regulations for medical devices (MDR).


OBJECTIVES

1.        Understand the regulatory requirements for relevant products used by dental professionals

2.        Understand the impact of the regulatory changes to their work

3.        Plan for ensuring compliance with the regulatory changes

4.        Contribute to improvement of medical devices and patient safety

Crina Cacou, Senior Medical Device Specialist, Medicines and Healthcare products Regulatory Agency (MHRA)