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US FDA medical device user fees see modest increase for 2022

Feb 8, 2023

HFR&D Webinar Debrief: December 2022 Draft US FDA Guidance on HFE for Medical Devices

Key questions from HFR&D webinar attendees on new US FDA human factors engineering guidance for medical devices

Feb 8, 2023

Wiklund's Perspective: Patient Deaths Due to Medical Error

The central role human factors engineers play in efforts to mitigate and reduce medical errors

New Brazil INMETRO ordinance eases inspection and documentation requirements

Feb 7, 2023

Brazil Update: Does RDC 751/2022 Simplify the Grouping of Devices?

Brazil update: Does RDC 751/2022 simplify the grouping of devices?

20th Notified Body designated under EU MDR while IVDR designations lag

Feb 7, 2023

Everything You Wanted to Know About EU Expert Panels for MDR and IVDR Compliance

Recent developments regarding EU expert panels pertaining to the MDR and IVDR

Feb 3, 2023

Brazil’s New RDC 751/2022 and the Technical Dossier Regulatory Submission

Effective March 1, 2023, the technical dossier must be structured as described in Brazilian medical device regulation RDC 751/2022.

Feb 3, 2023

The Age-Old Question: HFE, Usability, ID, UX or UI?

Distinctions between human factors engineering, usability and user experience

Feb 2, 2023

Brazil’s New RDC 751/2022 Incorporates European MDR Risk Classification Rules

Brazilian regulators align medical device classification rules to those of EU MDR

Feb 1, 2023

European Commission Proposal for Amending MDR, IVDR Makes Progress

The European Council has published a proposal for amending (EU) 2017/745 and (EU) 2017/746.

Jan 31, 2023

US FDA and Health Canada Launch eSTAR Pilot

The US FDA and Health Canada have announced the launch of their joint eSTAR pilot program, an interactive medical device submission form.

Additional data entry modules now online for European medical device, IVD registrants

Jan 30, 2023

European Commission Reports on Clinical Evaluation Consultation Procedure for Medical Devices

First EC annual report published on medical devices subject to MDR CECP requirements

US FDA formally proposes aligning Quality System Regulations with ISO 13485

Jan 25, 2023

US FDA Issues Final Rule to Streamline Radiological Health Regulations

The US FDA issued a final rule to streamline the radiological health regulations and clarify certain provisions.

Jan 24, 2023

UK MHRA Updates Roadmap for New Medical Device Regulations

UK regulators cover near-term plans to roll out new medical device market requirements

Jan 19, 2023

Canada Update: Proposed Amendments to Regulations on Licensing Drugs and Medical Devices

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.

Jan 17, 2023

European Regulators Clarify Standard Fees for MDR, IVDR

The European Medical Device Coordination Group (MDCG) has issued new guidance on standard fees for the MDR and IVDR.

Jan 17, 2023

KSA Update: New Guidance on Saudi Medical Device Classification and More

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.

Jan 10, 2023

Japan Update: Notifications on Used Medical Device Sales; Simplification of Procedures for Online Applications; and More

Japanese regulators issued regulations on used medical device sales; simplification of online applications procedure, and more.

China Update: IVD classification rules, medical device self-testing requirements

Jan 6, 2023

China Update: Announcement No. 124 of 2022; Draft Guidelines for the Registration of Implantable Medical Devices

Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries

Jan 6, 2023

What's in Store for the EU Medical Device and IVD Sectors in 2023?

Key issues regarding European MDR and IVDR compliance and implementation heading into 2023

Jan 3, 2023

EC Names Eighth Notified Body for IVDR

The European Commission (EC) has named QMD Services GmbH as the eighth Notified Body designated to the In Vitro Diagnostic Regulation (IVDR).

Dec 16, 2022

Applying the US FDA's New Human Factors Engineering Guidance for Medical Device Submissions

Our Human Factors Research & Design team takes a closer look at new FDA HFE guidance for medical devices

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