The REAL FACTS! Do not jump higher than you need!
Brexit - Details
- What you need to do to get your products notified with the MHRA.
- Expectations from the Competent Authorities and Notified Bodies.
- Chapter 2 Art. 11, 13 and 14.
- Qualifications, responsibilities and liability.
- The new medical device Regulation distinguishes between incidents and serious incidents. What is reportable with the authorities?
Post Market Surveillance
- Post Market Surveillance, as described in the new Medical Device Regulation, is a new concept!
- When to make use of Art. 61.10.
"Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate."
Workshop will be offered via Zoom meeting