13 February 2019 at 9:00 am - 4:00 pm
- This event has passed.
SMEs and confidently tackling the Medical Devices Regulations
OVERVIEW
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 as well as the Medicines and Healthcare products Regulatory Authority (MHRA) to understand the requirements for regulation from an industry and authority perspective. UK’s competent authority to get the full picture of how the new regulations will affect you.
PROGRAMME
You will learn about the:
Requirements for Regulation and Industry Perspective:
- Overview of New Legislative Framework and CE-Marking
- Classification
- General Safety and Performance Requirements
- Conformity Assessment
- Use of Standards
- Business needs
- 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
- Notified Bodies
- Registration of product
- Software, Digital, Annex XVI products (Classification rules etc)
- Post Marketing Surveillance and Vigilance
- Guidelines
- Contact points.
More information can be found here.
REGISTRATION
You can register online now.
