News in Brief

Belgium brings in complicated new country-specific registration requirements while awaiting Eudamed

Belgium has brought in new registration requirements for medical device and IVD operators in advance of the full application of the EU’s medtech regulations and new Eudamed medical device database.

Posted on 15. August 2018

GDPR: The various ways Medtech is affected, and needs to comply

The General Data Protection Regulation (GDPR) went into operation all through the EU, including the UK, on May 25. Medtech, along with every other industry has been preparing itself for this. But the impact of GDPR is extensive and there … Continue reading

Posted on 13. August 2018

Unease grows among notified bodies about possible reopening of PIP case

Medtech notified bodies have to keep an eye on PIP liability matters again as France’s top courts intervenes. This could result in a reopening of the TÜV Rheinland liability case. What would this entail for notified bodies overall?

Posted on 10. August 2018

Essential EU nomenclatures under new regulations gratis for users, document states

The future nomenclature to support the running of the Eudamed medical device database will be for free for manufacturers and others obliged to use it by the new EU Medical Device and IVD Regulations.

Posted on 18. Juli 2018

International safety reporting scheme will not be included in Eudamed database

EU does not have plans to integrate the future functions of the international National Competent Authority Report (NCAR) scheme into the EU’s new and updated Eudamed medical device database.

Posted on 17. Juli 2018

Pivotal EU document released to help understand EN ISO 13485

EU legislators have just issued a new document to help manufacturers and notified bodies fulfil the quality system requirements of the new EU device and diagnostics regulations.

Posted on 15. Juli 2018

Are you aware of EU MDR/IVDR deadlines? Explanations include a few surprises

The implementation timing of the EU’s new Medical Device and IVD Regulations is complicated. The texts expect the possibility of not having enough time to establish all the required structures, and, consequently, they include some intricate transitional arrangements. But many … Continue reading

Posted on 18. Juni 2018

Notified bodies apply for same or wider scope under MDR

10 members of the TEAM-NB European notified body association that are submitting an application to be designation under the new Medical Device Regulation (MDR) are also going to be applying for a wider scope than that for which they are … Continue reading

Posted on 16. Juni 2018

New EU Devices Regulations deficient as a safety and effectiveness check, says German study

The new regulation directing medical devices in the EU is deficient in the necessary requirements for compulsory high-quality evidence on the effectiveness and safety of products, report authors of a Germany study inspecting the scientific evidence used in health assessments … Continue reading

Posted on 14. Juni 2018

Commission clarifies non-recognition of UK organisations in future EU

UK organisations are about to disappear off the EU scene when it comes to medtech regulation and all stakeholders have only a little more than a year to make sure they are not involved in the possible outcome. This will … Continue reading

Posted on 27. April 2018
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