EMERGO SUMMARY OF KEY POINTS:

• New European regulations for medical devices and IVDs will enter into power in May 2017.
• Full implementation deadlines for the MDR and IVDR now appear set for May 2020 and May 2022, respectively.
• So far, parties discussing translation of the Regulations into English have been able to avoid having to reopen formal negotiations.

During the Eudamed Steering Committee meeting of December 14, 2016 the current state of play regarding the introduction of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) was presented by European Commission officials.

It appears the current process of translating the Regulations has indeed caused some discussions on the details of this complex legislation. Discussions are currently happening between the parties involved, and the need to reopen formal negotiations has been avoided.

So far this approach seems to work, because the Commission has now presented the following time table:

• At the end of January 2017 the English versions of the MDR and IVDR are expected to be ready;
• By the middle of February 2017, English versions as well as the translations into all European Union languages will be distributed among stakeholders;
• By the beginning of March 2017 the Council is expected to accept this version;
• By the beginning of April 2017 the European Parliament should adopt the Regulations;
• The formal publication would then take place at the end of April 2017;
• Official entry into power by the end of May 2017;
• The MDR would then be applicable from the end of May 2020;
• The IVDR would then be applicable from the end of May 2022.

Emergo will report on further details about the formal publication and an analysis of this official version as that information becomes available.

Set your watches, cancel all vacations; there is work to be done!

Additional information on implementation timelines for the Regulations in Europe can be found in our whitepapers on MDR and IVDR transitions and deadlines.