MDR or not MDR, that is the question... Not any longer
The EU MDR deadline officially postponed to May 2021
On April 3rd, 2020, the European Commission published a proposal to postpone the implementation of the new MDR by one year - until 26 May 2021. This proposal was drafted in the context of the fight against the Coronavirus pandemic.
In doing so, the commission has adopted a pragmatic approach, in an unprecedented world sanitary crisis, with the aim of preventing any risk of medical device shortage due to the impossibility for a number of manufacturers to comply with the requirements of the new regulations and due to the unavailability, in these extraordinary circumstances, of authorities and conformity assessment bodies to ensure proper implementation of the regulation.
The commission advocated that the postponement would allow increased availability of vitally important medical devices by ensuring the continuity of smooth functioning of the internal EU market and therefore maintaining a high level of patient health and safety until the application of the new legislation.
Stella Kyriakides, Commissioner for Health and Food Safety, explained: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today's decision is a necessary measure in these very exceptional times.” (Full intervention here)
Prior to the announcement, pressure came from manufacturers: On March 23rd, the trade Association MedTech Europe had called on EU institutions to postpone the application of the new MDR in the context of the coronavirus. Same demands came out of a number of European MPs as “fewer resources are available to ensure the implementation of the regulation”, they justified.
Today it is official, the European Parliament and the Council have voted the amendment proposed by the Commission, formerly pushing back the deadline to May 26, 2021.
This appears to be good news for the medical industry. First, it allows all efforts to be focused on the present crisis. But this postponement will also grant all the manufacturers that were struggling to organise themselves in time, and who have welcomed the news with great relief, to set up more planning while spreading costs throughout the year.
Baguette Translations has published guidelines for organising the translation process of your technical documents, see "Of MDR and Translations". We published a table that sums up the different steps of the process. The drafting and translating of your technical documentation should be planned early enough, as the documents will be required prior to the registering phase.
This one year delay should be seen as a great opportunity to carry out the compliance upgrade effort without pressure or missteps.
Until then, stay home and safe.
1 https://ec.europa.eu/commission/presscorner/detail/en/IP_20_589
