Europe – NF EN ISO 20916 – Mars 2024 – Dispositifs médicaux de diagnostic...
Le présent document définit les bonnes pratiques pour la planification, la conception, la conduite, l'enregistrement et l'établissement du rapport d'études des performances cliniques menées...
UK – Borderline products: how to tell if your product is a medical device...
Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...
Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
Europe – IVDR implementation day overshadowed by lack of notified bodies, risks to patients
While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not...
Europe – The Future of Europe’s Medical Technology Regulations
MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical...
Europe – Commission publishes implementing regulation on specifications for class D diagnostics
For certain class D in vitro diagnostic medical devices falling within the scope of Regulation (EU) 2017/746, harmonised standards do not exist as regards certain...
Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
Europe – Uniformiser le processus d’enregistrement des DM à l’échelle de la planète
Le paysage réglementaire mondial continue d'évoluer rapidement en matière de medtech ; de nouvelles exigences sont mises en place et le nombre de marchés...
UK – New action to tackle ethnic and other biases in medical devices
Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...
Europe – SSCP expert lists common mistakes device manufacturers make
Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but...
