In less than one year, the transition period will come to its end and the MDR regulation (2017/745) will fully apply.
As mentioned in article 123.2, the Regulation will fully apply on its Date of Application, set for 26 May 2020. This will mark the end of the transition period. Many changes will be applicable from this date, which will affect manufacturers world wide.
MDD certified and compliant devices may continue to be placed on the market of EU with the following conditions:
- the related MDD certificate is still valid
- there is no significant change in the product
- the requirements related to Market Surveillance, PMS, vigilance and registration of economic operators and of devices are in accordance with the regulation
What are the most important things to do?
- Perform gap analysis
- Check expiration day of your MDD certificates
- Make a plan for transition
- Start doing it right away
- Consult with your Notified Body
- Check the availability and appropriateness of the Clinical Data
- Implement the changes in your system
Having shortage in manpower or experts ?
HungaroTrial is here to help you with ex-Notified Body staff, clinical experts, and 20 + years of experience in Clinical Studies.