MDR 2017/745

Eudamed Update: Actors module testing

EMERGO SUMMARY OF KEY POINTS:

  • The Eudamed project is following its original schedule.
  • The  first module has been tested by users.
  • The development of specific procedures by the Competent Authorities is outside the reach of the Commission, but this will just be as important as the development of Eudamed.
  • Industry needs time for developing and testing their interfaces, and this could be set up by giving them access to the draft modules.

Eudamed Nomenclature Requirements Published

EMERGO SUMMARY OF KEY POINTS:

  • The MDCG endorsed the requirements for nomenclature to be used in Eudamed.
  • This nomenclature will be made available for free to stakeholders and others.
  • Availability of the nomenclature in all EU languages is considered highly important, but it is not worded as a hard requirement.
  • It can be expected that the nomenclature system will be selected in 2018, although there is no confirmation by the authorities on that timeline.

Switzerland to Model Medical Device Regulations on European MDR Requirements

EMERGO SUMMARY OF KEY POINTS:

  • Swiss medical device market regulators are realigning their requirements to match those of the European MDR and IVDR.
  • Switzerland is revising its Medical Devices Ordinance (MedDO) using a staged approach, with completed revisions planned for 2020.

UK, European Device Industries Urge Continued Regulatory Alignment Post-Brexit

EMERGO SUMMARY OF KEY POINTS:

  • UK and European medical device and IVD industry trade groups are arguing for full MDR and IVDR implementation in Great Britain during and after Brexit negotiations.
  • The groups seek European recognition of UK Notified Bodies and Authorized Representatives as well as full access to the Eudamed database by the UK MHRA.
  • Whether Brexit negotiators adequately address the trade groups’ concerns remains an open question.

UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations.
  • The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

Entry into Force Milestone Reached for European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • The European Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Regulations (IVDR 2017/746) have been entered into force as of May 26, 2017.
  • The Regulations’ entry into force is the last milestone before full implementation of the MDR in May 2020 and the IVDR in May 2022.