As officially stated by the EU Parliament on April 17, 2020, the Parliament decided to postpone the application date (May 26, 2020) of new requirements for medical devices (EU MDR/745/2017) by one year. This decision was made on the proposal prepared by EU Commission in order to prevent shortages or delays in getting key medical devices on the market, Parliament decided to postpone the application of the Medical Devices Regulation.
The adoption by the European Parliament and the Council of the proposal to postpone by one year the date of application of the MDR was published on April 23, 2020. 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 put into effect officially.
EU Official Journal (EU Regulation 2020/561)
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 May 26 of this year to May 26, 2021. Eventually, the EU Official Journal has made the proposal by the decision-makers of EU organizations legally effective.
Following this formal decision, we are currently defining how TÜV Rheinland will handle MDD certification for the next 13 months as an EU Notified Body for MDR 2017/745 & MDD 93/42EEC. An official announcement will be made separately.
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