With the transition period for the new European Medical Device Regulation (EU) 2017/745 (MDR) coming to an end in May 2020, it is imperative that manufacturers take action to update their technical documentation and processes to meet the new requirements.
The MDR, which replaces the Medical Devices Directive (93/42/EEC), brings with it more scrutiny of technical documentation, addressing concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up and requiring better traceability of devices through the supply chain.
RSSL's in-depth MDR training is designed to help you and your team prepare for these challenges to facilitate a smooth transition to the MDR. This includes learning how to interpret and navigate new regulations, determine device classification and understand conformity assessment routes.
The course will also address the enhanced requirements under the new regulation, General Saftey and Performance Requirements (GSPRs), clinical evidence and post-market surveillance as well as covering the requirements to keep your device compliant under the exitsing Medical Device Directive while ensuring your CE Certificate remains valid.
To learn more about this course and book for place, please click here.