Europe – Commission welcomes adoption by European Parliament of measures to improve the availability...
The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
UK – MHRA expected to launch recognition framework for devices
According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is...
Europe – Désignation d’AFNOR Certification dans le cadre du règlement UE 2017/745, relatif aux...
Désignation d'AFNOR Certification dans le cadre du règlement UE 2017/745, relatif aux dispositifs médicaux...
USA – FDA publishes new dataset to aid medical device biocompatibility testing
The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that...
Brazil – Brazil to recognize other agencies’ decisions on devices
In a step toward consolidating regulatory reliance, The Brazil Health Regulatory Agency (ANVISA) said on 8 April that it would recognize decisions by regulators...
Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations...
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by...
Europe – MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical...
Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of...
Europe – TÜV SÜD Danmark ApS today received its designation as Notified Body 2443...
TÜV SÜD Danmark ApS today received its designation as Notified Body 2443 under Medical Device Regulation 2017/745 by the Danish Medicines Agency (DKMA). Notified...
Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires
that the manufacturer shall draw up a summary of safety and performance (SSP)...
