Date: 9th (1) and 10th (2) of December 2020 (2 sessions)
Time: 16:00h -18:00h CET / 10am - 12pm EST
Costs: € 895,-
Manufacturers struggle to address requirements for clinical evaluation for all classes of devices, with many erroneously assuming class I devices will not need clinical data. Clinical evaluation is required for all medical devices regardless of risk classification or clinical data requirements. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant General Safety and Performance Requirements remains unchanged, the medical device regulation (MDR) 2017/745 along with the recently published MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence and MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices includes stringent requirements for acceptable clinical data, demonstrating equivalence to a marketed device, and the ability to establish conformity for devices in which clinical data is not deemed necessary (Article 61 section 10).
These virtual training sessions will walk you through how to establish endpoints for clinical claims that will make identifying and assessing relevant literature and other clinical data sources more straight-forward. Practical examples of devices that meet the requirements of Well-Established Technology or MDR Article 61 (10) will be provided as will common pitfalls for establishing equivalence.
Learning objectives (part 1)
- Identifying performance and safety claims with measurable endpoints and acceptance criteria
- Linking performance and safety to clinical benefit
- Establishing the benefit/ risk ratio
- Content requirements for CEP, CDP and CER
Learning objectives (part 2)
- MDCG 2020-5 Guidance on Equivalence under the MDR
- PMS under the MDR
- MDCG 2020-6 sufficient Clinical Evidence for Legacy Devices
- Identifying clinical data needs (Equivalence, literature, adverse events, complaints, SoA)
- Quantifying device performance and safety