13 Feb 2019
09:00 - 16:00
etc.venues Manchester 11 Portland Street Manchester M1 3HU
About the event
The new EU Medical Devices Regulation (EU 2017/745) entered in to force in May 2017, which expands on the CE-Marking requirements under the Medical Devices Directive (93/42/EEC) that manufacturers have to meet to place medical devices on the market in the European Union.
The new Regulation (MDR) brings in a greater business focus, more scrutiny of technical documentation, enhanced clinical evaluation and post-market clinical follow-up, and traceability of devices through the supply chain.
This one-day workshop aims to help small and medium-sized enterprises (SMEs) to develop the tools necessary to comply with new Medical Devices Regulation and then how to apply these tools to the overall business development strategy.
You will hear from industry experts including the Medicines and Healthcare products Regulatory Authority (MHRA), NICE and who will outline their role in medical device regulations and the recent Evidence Standards Framework for Digital Health, NHSE discussing the subject of Tariff’s and Reimbursements, as well as an Industry case study. There will also be the opportunity to have one-to-one sessions with the keynote speakers (booking required) to answer any questions and provide advice on issues of particular relevance to your organisation.
Who should attend?
SME medical device manufacturers, especially if your role includes:
What will I learn?
You will learn about the:
Expectations of the Authority:
How will I benefit?
On completion of this course, you will be able to: