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Jerkmate
https://www.raps.org/resource/notified-body-group-raises-safety-concerns-about-targeted-mdr-ivdr-revision.html
Notified body group raises safety concerns about targeted MDR, IVDR revision | RAPS
Apr 20, 2026 - The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device...
raises safety concernsmdr ivdrnotifiedbodygroup
https://oostnl.nl/events/mdr-en-ivdr-richtlijnen-voor-med-tech-hardware-en-software
MDR & IVDR: Richtlijnen voor MedTech Hardware en Software | Oost NL
mdr ivdrrichtlijnen vooroost nlmedtechhardware
https://www.freyrsolutions.com/medical-devices/regulatory-strategy-consultation-for-samd
SaMD Regulatory Strategy Consultation | EU MDR/IVDR
Freyr offers regulatory strategy for SaMD—classification, registration, and QMS compliance ensuring international market readiness.
regulatory strategyeu mdrsamdconsultationivdr
https://www.medtechdive.com/news/eu-builds-out-mdr-ivdr-guidance-ahead-of-flurry-of-implementing-acts/605455/
EU builds out MDR, IVDR guidance ahead of flurry of implementing acts | MedTech Dive
The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the...
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https://www.assured.se/areas/medtech-security
Medtech Security - IEC 62304, IEC 62443, HIPAA, FDA, MDR, IVDR | Assured AB, Security Consultants
We help secure medical devices, apps and healthcare systems, ensuring compliance with relevant standards and regulations for the Swedish, European and US...
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https://etikprovningsmyndigheten.se/medicintekniska-produkter/
Medicintekniska produkter (MDR) och medicintekniska produkter för in vitro-diagnostik (IVDR) -...
Mar 2, 2026 - Sedan den 26 maj 2021 gäller EU:s förordning 2017/745 om medicintekniska produkter (MDR). Från den 26 maj 2022 gäller även EU:s förordning 2017/746 om...
produktermdrochvitrodiagnostik
https://confinis.com/mdr-ivdr-switzerland/
Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR): Impact on...
May 10, 2024 - Soon the final version of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) will be published. Both will have a...
medical device regulationvitro diagnosticmdrivdrimpact
https://www.bsigroup.com/en-GB/products-and-services/medical-devices/article-164-certification-mdr-and-ivdr/
Article 16(4) Certification (MDR and IVDR) | BSI
BSI is designated to issue article 16(4) certificates for all types of medical devices and IVDs that are subject to activities laid down in Article 16(2).
16 4ivdr bsiarticlecertificationmdr