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MedTech Europe: Revised Manufacturer Incident Reporting form and new Vigilance-related guidance documents published

Revised Manufacturer Incident Reporting form and new Vigilance-related guidance documents published
The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents: • New manufacturer incident report (v7.2 PDF form) • New manufacturer incident report for importing XML file with Adobe Professional • New manufacturer incident report XSD files (for implementation in manufacturer' databases) • New […] The post Revised Manufacturer Incident Reporting form and new Vigilance-related guidance documents published appeared first on MedTech Europe.
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Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices
The European Commission has published a Call for expression of interest for expert panels on medical devices and in-vitro diagnostic medical devices. This call is based on the Commission Implementing Decision EU 2019/1396, which was published on 10 September 2019. Experts of the panels will be selected by the Commission on the basis of their […] The post Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices appeared first on MedTech Europe.
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Phthalates: Final SCHEER guidelines published
On 9 September, the Scientific Committee on Health and Environmental Risks (SCHEER) published the final version of its Guidelines on benefit-risk assessment (BRA) of phthalates in certain medical devices. The Commission mandated SCHEER to develop such Guidelines in accordance with Annex I, Section 10.4.3. of the Medical Device Regulation. The Guidelines describe the methodology on […] The post Phthalates: Final SCHEER guidelines published appeared first on MedTech Europe.
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