The new MDR (Medical Device Regulation) 2017/745 has raised the bar on not just the requirements surrounding clinical evidence, but the level of examination now carried out by notified bodies on Clinical Data.
The EU MDR is setting the framework for busy times ahead for medical device practitioners looking to meet the new higher bar requirements set out by the MDR and clinical evidence plays a big role in increased workload. The Frequency of updates to the Clinical Evaluation Report (CER)has changed. Qualifications of report authors and evaluators is now under scrutiny. You now must define Specific and measurable objectives for the CER and establish Scientific validity of data been presented to the notified body. Updates to CERs may also trigger updates to Instructions for Use; make sure they are in alignment. Clinical investigations must be conducted within the constructs of the new legislation and recognized ethical principles.
- Understand what is Clinical Evaluation and what are the Clinical Evaluation Guidance Documents
- Understand Clinical Evaluation Requirements under new MDR
- Understand Methodology employed to carry out CER (Clinical Evaluation Report)
- Understand the Requirements of Literature Search and Screening
- Understand the Fundamentals of good medical writing
- Greater understanding of layout oy CER (Clinical Evaluation Report)
- Compliance to Post Market Clinical Follow up
If you want to find out all about the new MDR (Medical Device Regulation) 2017/745, book a place on the training course we have scheduled for 25th November.