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:
Design and Development
Clinical Affairs Specialists
What will I learn?
You will learn about the:
Requirements for Regulation and Industry Perspective:
Overview of New Legislative Framework and CE-Marking
General Safety and Performance Requirements
Use of Standards
Key Milestones (from a project management perspective
Timelines i.e. European level developments (Agency perspective)
Expectations of the Authority:
Role of the Authority
Clinical Trials and Clinical Data
Registration of product
Software, Digital, Annex XVI products (Classification rules etc)
Post Marketing Surveillance and Vigilance
How will I benefit?
On completion of this course, you will be able to:
Understand the key changes in the transition from the Directives to the MDR
Develop a project plan for product development that includes critical regulatory steps
Communicate the impact to your organisation of the key changes introduced by the
MDR, and the transition arrangements defined within the MDR
Identify the next steps for your organisation to meet the MDR requirements.