Europe Blog Posts

Europe's Eudamed Database: Five Key Questions (Part 2)

In Part Two of Emergo’s series identifying five major questions regarding Eudamed compliance under Europe’s Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR), we cover issues including roles and responsibilities of importers, distributors and Authorized Representatives, plus clinical and performance study issues.

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Europe’s Eudamed Database: Five Key Questions (Part 1)

Compliance with Eudamed database requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) may be years away, but preparation for the new requirements will take sustained effort. We've identified key issues many manufacturers are dealing with ahead of Eudamed's launch.

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In Brief: Swiss Regulators Moving to Online Medical Device Certification

Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources.

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Dutch Ministry of Health: Prepare for a "Cliff Edge Brexit"

EMERGO SUMMARY OF KEY POINTS:

  • After Brexit there will be a border, with the UK outside the EU.
  • Customs Union or EEA options are unlikely outcomes.
  • Prepare for a hard Brexit (‘Cliff Edge Brexit’) on 29 March 2019.
  • A hard Brexit will likely impact all organizations, even if you do not interact with the UK.
  • Disclaimer: This blog only gives a limited update on the current situation. We can only speculate as to what the final outcome will be.
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The Role of Post-market Surveillance in the European Medical Devices Regulation (MDR): Key Questions

Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS. 

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MDR and IVDR Update: Publication of Labels and Instructions for Use on Manufacturers’ Websites

EMERGO SUMMARY OF KEY POINTS:

  • The European MDR and IVDR require medical device manufacturers to publish user information on their websites.
  • Publishing user information on a manufacturer’s website makes Regulation (EU) 207/2012 on e-labelling applicable.
  • The e-labelling Regulation is only applicable to medical devices, not for IVDs.
  • This simple requirement may have consequences for firms’ quality management systems as well as their agreements with importers and distributors.
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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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