OFFICIAL: MDR postponed by one year as industry enjoys a slight reprieve
After the EU Commission’s proposal to delay Medical Device Regulation (MDR) due to the coronavirus was voted for by the European Parliament on the 17th April 2020, the postponement was published in the EU Official Journal at the end of April, making it official.
The new Medical Device Regulation (EU MDR/745/2017) was introduced in 2017 and allowed companies three transition years to meet the new MDR requirements. The switch-over date was scheduled for 26th May 2020.
As the outbreak of coronavirus spread throughout Europe, turning the Medtech industry’s attention to tackling the pandemic, groups of manufacturers, trade associations and more lobbied to have the deadline date pushed back.
As pressure mounted on EU regulatory bodies amid concerns of shortages or delays in getting key medical devices on the market, the EU Commission adopted a proposal on the 3rd April to postpone MDR until the 26th May 2021.
On the 17th April, the proposal was overwhelmingly in favour of by the European Parliament but before it could be made official, however, the proposal had to be published in the Official Journal.
With the publication of the EU Official Journal on April 24, 2020, the measure to postpone the application date of EU MDR 2017/745 by one year was formally put into effect.
Specifically, the new EU Regulation 2020/561 in a form of EU Official Journal was issued to amend the relevant texts set out in EU MDR 2017/745 to postpone the effective date from the 26th May of this year to 26th May 2021.
The publication in the EU Official Journal has made the proposal by the decision-makers of EU organisations legally effective.
The delay will provide the industry with a slight reprieve after moving quickly to combat the COVID-19 outbreak, giving companies a chance to finalise MDR preparations.
Last month, the British Healthcare Trades Association outlined why MDR will not just have a bearing on manufacturers but will also impact retailers, including what mobility dealers should do to prepare for the regulatory change.
