Europe Blog Posts

Spring 2018 Updates to European Medical Device Borderline and Classification Manual

EMERGO SUMMARY OF KEY POINTS:

  • A new version of the Manual on Borderline and Classification has been published.
  • The seven new positions do not contain surprises.
  • It appears the MDEG is not yet involved in device status or classification questions regarding the MDR or IVDR.

On April 23 2018 the European Commission published Version 1.19 of the Manual on Borderline & Classification. Following the release of Version 1.18 in December 2017 it appears the Medical Devices Expert Group (MDEG) on Borderline & Classification is quite active.

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European Medical Device Regulatory Roundup: May 2018

Major changes underway in the European medical device and IVD markets require manufacturers to keep up with many complex moving parts. Issues including implementation of the MDR and IVDR, ramifications of Brexit and tightening Notified Body requirements have resulted in a more challenging CE Mark certification process for many companies.

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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.
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European Regulators Publish UDI Guidance

EMERGO SUMMARY OF KEY POINTS:

  • The Basic UDI-DI is the key identifier of a device in Eudamed, on certificates and on the Declaration of Conformity.
  • Multiple UDI-DIs can be linked to a single Basic UDI-DI, while a UDI-DI must be linked to only one Basic UDI-DI.
  • The UDI-DI must unambiguously identify a device in the distribution chain; any change that may confuse identification should result in a new UDI-DI.
  • Manufacturers can now identify the data elements and formats for developing their databases in preparation of the introduction of UDI in Europe.
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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.
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Brexit Agreement: Reset your clocks!

EMERGO SUMMARY OF KEY POINTS:

  • European and UK negotiators strike a deal
  • Transitional period until 31 December 2020: 21 months extra
  • The MDR will apply in the UK; it is likely this will also happen for the IVDR
  • A mutual agreement would enable movement of medical devices between the UK and EU, but whether this is politically achievable remains unknown
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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.
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Eudamed Accessibility for Non-European Authorities

EMERGO SUMMARY OF KEY POINTS:

  • Some information in Eudamed will be publicly accessible.
  • Typically, non-European authorities only have access to publicly available Eudamed data.
  • The MDR and IVDR keep the option open for non-European countries to exchange data with Eudamed and have access to data that is not publicly accessible, based on reciprocity.
  • The European Commission has indicated IMDRF members of the NCAR system will be the first to get extended access.
  • Eudamed could be a new world standard in data exchange regarding device safety.
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UDI for Medical Devices Going Global

EMERGO SUMMARY OF KEY POINTS:

  • Most markets all over the world will have a system for Unique Device Identification within five years.
  • It will likely be possible to have a single code on each device for all these markets.
  • It is likely that those codes will be linked to different databases for each market.
  • In March 2018 the European Commission will publish a guidance document on UDI under the MDR and IVDR.
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Brexit: The Hard Reality of “No Deal” for the Medical Device Industry

EMERGO SUMMARY OF KEY POINTS:

  • All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit.
  • The distribution network of medical devices currently placed on the market by UK based importers must be reviewed.
  • EU distributors currently placing UK manufactured devices on the market may have a different role.
  • Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019.
  • Notified Bodies are already anticipating this scenario.
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