BREAKING NEWS – As part of the Corona-Virus response activities of the European Commission, important decisions in regard to the Regulation (EU) 2017/745 (MDR) will be made in the upcoming weeks.
In a tweet, the EU Commissioner Stella Kyriakides announced that the EU Commission plans to postpone the start of the MDR for one year. A corresponding document is currently being drawn up. The aim of the commission is to get the approval of parliament and council by the beginning of April, a EU-spokesman told in a press conference of the Commission on March 25.
Vital medical devices are needed to treat COVID-19 patients and must remain available on EU-markets without any disruption. For this reason, the EU-Commission, is working put forward a proposal to delay the implementation of the new medical devices regulation (MDR) by 12 months. This proposal will be submitted early April with the call on the EU-Parliament and the Council to adopt this proposal quickly before the second half of May.
The coronavirus pandemic has numerous immediate effects on the final run for the MDR: first notified bodies close or are limited in their activities. There are no more on-site audits. Authorities are affected and distracted. Companies and production facilities are also affected or have to make changes due to the pandemic. Suppliers break away. And this at a time when the industry is building up additional production capacities to meet the increasing demand due to the coronavirus outbreak.
This measure will release unnecessary pressure from national authorities, notified bodies and industry and will allow everyone to fully focus on urgent priorities of the medical device markets related to the Coronavirus. Therefore this appears the best possible step to delay a process that was already delayed and focus on public safety and health.
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