Both the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) were presented to the European Council and European Parliament in early March, 2017, and finally adopted on April 5, 2017, replacing the existing directives.
A copy of the text, dated March 8, 2017, Rev 4, can be found here.
Its publication in the Official Journal of the European Union (OJEU) is anticipated within a few weeks, with Entry into Force coming 20 days later.
The changes are wide and varied, and there are now 123 Articles, 17 Annexes and 566 pages which will impact on every medical device manufacturer – as their products will be affected one way or another.
The publication of both Regulations concludes a significant amount of work over recent years, with the main driver being the improvement of patient safety, along with some provisions to improve the overall effectiveness of the processes associated with affixing the CE Mark.
What should you do? Do not panic.
Monitor the OJEU for the actual publication of the text of the regulation.
If you have a scheduled audit by your Notified Body prior to the Regulations being published, take the opportunity to speak with the Auditor.
Keep progressing with your transition plans for EN ISO 13485:2016 to achieve Certification, as this provides compliance with some of the requirements in the Conformity Assessment Annexes and gives you the foundation for managing the other changes as you move from the Directive to the Regulation.
Next month – MDR Transition Plans