Rules for the entry of medical devices into UK markets are evolving rapidly. The UKCA mark for medical devices is in effect, new UK legislation is in place and a transition period has been defined (and re-defined). While there are still many uncertainties, manufacturers are already developing strategies for UK market access and are starting to implement them.

In this session, SGS, an MHRA/UK Approved Body, will discuss best practices, common challenges and strategies for UK market approval of medical devices. You will gain insight into the impact of new and existing devices on the market and learn how to adapt your regulatory strategies, ensure compliant documentation, manage quality management systems and update your technical documentation.

Objectives

This webinar will:

Explain the current state of play in the UK medical devices market as well as foreseeable updates, as of the date of the webinar.
Put medical device regulatory experts in an informed position so they can formulate and update their regulatory strategies
Shape expectations and share mechanisms for coping with rapidly changing information
Describe the dos and don'ts for UK compliant technical documentation
Explain the impacts on quality management systems

Agenda

Introduction
Current UK regulatory environment and transition timelines
Foreseeable updates, as of the date of the webinar
Regulatory strategy scenarios, e.g. products that are already MDD certified vs new products, with or without EU Regulations (MDR, IVDR)
Expectations and coping mechanisms for dealing with rapidly changing information
Best practices for setting up a UKCA compliant QMS and creating product technical documentation
Q&A

For further information, please contact:

Dominic James

Marketing Assistant

t: +1-201-508-3000