EU MDR Postponed for One Year

SHENZHEN, China–(BUSINESS WIRE)–#TUV–As officially stated by 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 1 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. 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.

For your information

EU Commision website April 17

EU Commission website April 23

About TUV Rheinland

TUV Rheinland is a global leader in independent inspection services, founded nearly 150 years ago. The group maintains a worldwide presence of more than 20,000 people; annual turnover is EUR 2 billion. Its independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TUV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TUV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TUV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.TUV.com

Contacts

Jane Liang, TUV Rheinland Greater China

Tel: +86 755 8268 1325

Jane.liang@tuv.com