The postponement of the MDR by one year has been on the agenda

2020.03.26.

Our lives are changing at a rapid rate due to the COVID-19 epidemic. Things that were still certain points yesterday, are completely changing today and we have to adapt to the new situation immediately. COVID 19 affects almost every aspect of our privacy and work, and so has the introduction of MDR.

Earlier this week, the news was that several professional organizations, such as MedTech Europe and Medicines for Europe, had written to the European Commission to postpone the introduction of MDR.

The news came last night that the Commission had accepted the proposal and would take the matter to the European Parliament. The main sentence of the letter from the relevant Commission Directorate is as follows:

“Today (March 25, 2020) the Commission announced,…. work on a proposal to postpone the date of application of the MDR for one year is ongoing."We are working to submit this proposal early April and we call on Parliament and Council to adopt it quickly as the deadline for entry into force is end of May." This will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to focus fully on urgent priorities related to the coronavirus crisis."

The Commission emphasized furthermore, "We remain fully committed to the effective implementation of the new medical device legislation and will proceed with this important work – together with all actors involved." The Commission call on the attention of all actors to ensure that this is additional year is used appropriately and consciously and that all incomplete work leading up to the originally foreseen date of application is this time around appropriately completed.

It is obvious that all Hungarian manufacturers in this situation need to develop a new strategy for the MDR transition to which we seek to support in the following newsletters.