On the 26 May 2020, the Medical Device Regulation 2017/745 will replace the Medical Device Directive 93/74/EEC which has been operational since the 1990s. This is a significant change for all medical devices intending to be marketed in Europe after this date. Some of the main questions to be considered:
- Do I obtain CE marking under MDD or MDR?
- What new data will I need to provide to re-certify my existing device?
- What impact will the MDR have on other departments in my organisation?
- How do I comply with MEDDEV 2.7.1 Rev 4 and the new clinical requirements?
- I need a Clinical Evaluation Report to meet the requirements of MEDDEV 2.7.1 Rev 4 and the MDR.
- Gap analysis of your current files and systems to MDR Requirements
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›