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The central role human factors engineers play in efforts to mitigate and reduce medical errors
Brazil update: Does RDC 751/2022 simplify the grouping of devices?
Recent developments regarding EU expert panels pertaining to the MDR and IVDR
Effective March 1, 2023, the technical dossier must be structured as described in Brazilian medical device regulation RDC 751/2022.
Distinctions between human factors engineering, usability and user experience
Brazilian regulators align medical device classification rules to those of EU MDR
The European Council has published a proposal for amending (EU) 2017/745 and (EU) 2017/746.
The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive medical device submission form.
First EC annual report published on medical devices subject to MDR CECP requirements
The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions.
UK regulators cover near-term plans to roll out new medical device market requirements
Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees for the fiscal year 2023-2024.
The European Medical Device Coordination Group (MDCG) has issued new guidance on standard fees for the MDR and IVDR.
The Kingdom of Saudi Arabia (KSA) has introduced new guidance on medical device classification as well as other updates including guidelines for the use of radiation-emitting medical devices.
Japanese regulators issued regulations on used medical device sales; simplification of online applications procedure, and more.
Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries
Key issues regarding European MDR and IVDR compliance and implementation heading into 2023
The European Commission (EC) has named QMD Services GmbH as the eighth Notified Body designated to the In Vitro Diagnostic Regulation (IVDR).
Our Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices
An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.