What is MDR 2020/561?

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MDR 2020/561 Definition

Medical Device Regulation (MDR) 2020/561 is an EU regulation which amended the date on which MDR 2017/745 went into effect. The application date for MDR 2017/745 was postponed until May 26, 2021 in an effort to give medical device manufacturers, authorized representatives, importers, and distributors more time to renew their existing certificates under the Medical Device Directive (MDD).

What is MDR 2020/561

FAQs

Why is the MDR needed?

The EU Medical Device Regulation (MDR) was intended to replace decades old legislation with regulations that are more in line with the latest technological advances and medical science and create a more transparent regulatory framework that helps improve patient safety. In contrast to previous directives, the MDR does not need to be transposed into national law, thereby reducing the risk of discrepancies in interpretation across EU member states.

*Source: https://www.medical.saint-gobain.com

What does EU MDR replace?

The EU MDR replaces the previous Medical Device Directive (MDD) (93/42/EEC) and Active Implantable Medical Device Directive (AIMDD) (90/385/EEC). The EU MDR has a multiyear transition period, with May 26, 2021 as the date of application (i.e., when it becomes mandatory).

*Source: https://ec.europa.eu

Does MDR replace MDD?

Yes, the new Medical Device Regulation replaced the previous Medical Device Directive (MDD) on May 26, 2021.

The Essential Guide to EU IVDR Compliance

See if your medical device meets the new European Union (EU) Medical Device Regulation (MDR) requirements and how to stay in compliance in our guide.

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