Europe Blog Posts

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
Read more about Brexit Agreement: Reset your clocks!...

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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Europe: Development of Eudamed Well on Schedule

EMERGO SUMMARY OF KEY POINTS:

  • Eudamed functional specifications expected to be released in May of this year
  • Eudamed expected to go live in March 2020
  • As with all plans: there are some uncertainties regarding the execution of this plan
Read more about Europe: Development of Eudamed Well on Schedule...

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Human Factors Engineering (HFE) guidance from the UK MHRA differs in some areas from recommendations issued by the European Union.
  • The MHRA focuses its recommendations on HFE and usability engineering during medical device development.
  • In some areas, the MHRA guidance hews closer to US FDA recommendations than European standards.
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New European Borderline and Classification Manual Published

EMERGO KEY POINTS:

  • An updated version of the European Borderline and Classification Manual for medical devices and IVDs is now published.
  • The latest manual will be of limited use once the European Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) go into effect because of different definitions and classification rules.
Read more about New European Borderline and Classification Manual Published...

European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • European regulators have published high-level cybersecurity recommendations for industries including medical devices involved in the Internet of Things (IoT) paradigm.
  • The recommendations are partially intended to help companies meet upcoming European data privacy requirements under the General Data Protection Regulation, or GDPR.
  • The European report cites US FDA guidance regarding medical device cybersecurity principles and recommendations.
Read more about European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices...

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