EU: Key New Commission Documents Relating To EU Directives And New Regulations
The European Commission has recently published a host of information that is relevant to manufacturers preparing to comply with the new MDR.
Here you can find six documents that have recently appeared on the European Commission’s medtech website.
- MDCG 2019-9 Summary of safety and clinical performance – A guide for manufacturers and notified bodies – August 2019
- MDCG 2019-10: Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
- State-of-play of joint assessments of notified bodies in the medical device sector
- DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices
- Manufacturer incident report 2020, to be used from January 2020
- EU: New MDCG guidance on “Summary of Safety and Clinical Performance” under the Medical Devices Regulation (MDR)
- EU: The European Commission has published guidelines concerning the use of phthalates in medical devices
- EU: Key New Commission Documents Relating To EU Directives And New Regulations
- MEDCERT at MEDICA in Düsseldorf