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European Medical Device, IVD Regulations Now Officially Published

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EMERGO SUMMARY OF KEY POINTS:

  • The European Medical Device Regulations 2017/745 and In Vitro Diagnostic Regulations 2017/746 were published May 5, 2017 in the Official Journal of the European Union (OJEU).
  • Entry into force of the MDR and IVDR will therefore occur on May 26, 2017.
  • The date of application for the MDR will be May 26, 2020.

OJEU publication of MDR and IVDR May 2017The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices Directive (93/42/EEC -- MDD), while the IVDR will replace the In-Vitro Diagnostic Medical Devices Directive (89/79/EC -- IVDD).

Emergo consultants in The Hague note that the Regulations’ publication date tracks closely to timeframes laid out by the Commission in late 2016. Official publication of the MDR and IVDR is the last step before official entry into force of the Regulations; in this case, official entry into force will occur on May 26, 2017.

What happens next for MDR, IVDR implementation?

Now that European Commissioners have reached their OJEU publication milestone, European medical device and IVD market registrants should bear in mind the following remaining MDR and IVDR deadlines:

  • May 26, 2017: Official entry into force of MDR 2017/745 and IVDR 2017/746
  • November 26, 2017: Notified Bodies may apply for designation under the MDR and IVDR
  • March 26, 2020: Eudamed will go live
  • May 26, 2020: MDR date of application
  • May 26, 2022: IVDR date of application
  • May 26, 2024: AIMD, MDD and IVDD certificates become void (provided they have been kept valid up until this date); after this date, no more devices may be placed on the European market under these certificates
  • May 26, 2025: After this date, no devices may be put into service in Europe using MDD, AIMD or IVDD certificates

European MDR and IVDR resources from Emergo:

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