Are you ready for the significant changes under the new EU MDR and IVDR regulations?

Gap analysis and early preparation is key towards successful certification according to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements.

As one of the leading EU Notified Body for all types of medical devices and in-vitro diagnostics covered by EU directives and regulations, TÜV SÜD Product Service is prepared and working closely with the Authorities to get designation as a Notified Body under the new MDR and IVDR.

TÜV SÜD offers the following services to help you prepare:

  • General MDR and IVDR Training (Public and In-House)
  • Modular TD Assessments following the official application for certification
  • MDR and IVDR Workshops

Visit our MDR and IVDR webpages to find out more about the upcoming regulatory changes.

Download the MDR brochure [ PDF 1208 kB ] and IVDR brochure [ PDF 458 kB ] to learn more.

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MDR and IVDR FAQs

EU MDR

The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

  • Read more about the FAQs here.

EU IVDR
In coincidence with the EU Regulation on medical devices (MDR), the EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) entered into force on 26 May 2017. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).

  •  Read more about the FAQs here.

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