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The new Medical Device Regulation (MDR)

MDR replaces MDD: A new European regulation for medical supplies

The Medical Device Regulation (MDR) is the new EU regulation on medical products (EU 2017/745), which came into force at the end of May 2017 and, after a transitional period, is to be applied from May 2020 at the latest. It replaces the Medical Devices Directive (MDD). MDR is intended to significantly improve the quality, safety and reliability of medical devices and market surveillance mechanisms. HARTMANN has successfully demonstrated it is one of the leaders in preparedness for the new regulation. The company has accomplished a significant milestone with the completion of the MDR stage 2 audit and has even more evidence to claim: HARTMANN is MDR ready.

What's changing under MDR from 2020?

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• Focus on the entire product lifecycle with a view to safety, from the development stage right through to post-market surveillance and product end-of-life
• New requirements for clinical testing, technical documentation, device testing, labelling, packaging and post-market surveillance
• Every device must have a Unique Device Identification for improved traceability
• Manufacturers now play an active role during the post-market phase
• New database (EUDAMED) is being established to register all medical devices distributed in the EU

Timeline

The MDR entered into force in May 2017 with a three-year transition period until May 26th 2020. Class I devices must be certified under MDR by this date. Certificates issued under the MDD, before the full application of the MDR in 2020, will remain valid for up to 5 years, which means until 26th May 2024 at the latest.

Timeline-MDR

We are MDR ready

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Our goal is to keep our customers’ routines running smoothly, so they can focus on their patients.

  • MDR will apply to most of the products in HARTMANN’s portfolio. That’s why our internal task force has been working intensively on MDR compliance since 2017
  • As one of the first companies in the global market we went through a Stage 1 and Stage 2 audit against the MDR (and MDD) at the PAUL HARTMANN AG
  • We expect the MDR certificates by end of the year
  • We are communicating transparently when product ranges change and offer wherever possible adequate replacement for discontinued products
  • We are in close contact with our partners and suppliers
  • We support our customers during the entire transition phase

We are MDR ready and intend to have a fully compliant class I portfolio by May 2020.

We take care of MDR, so you can care better