Blog Category: Medical Device

MDR Regulations – Impact on Medical Devices

Medical Device

The EU Medical Device Regulation (MDR), effective since May 26, 2021, has brought significant changes to the global medical device industry. Outlined below are seven major ways the MDR is influencing...

Medical Device Labelling Requirements

Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Safe and effective operation of a medical device must never rely on guesswork. Clear, accurate, and compliant...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA

Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

Medical Device

EUROPE 1. Updated Information Pack for Candidate EU Reference Laboratories Regulation (EU) 2017/746 authorizes the European Commission to designate EU reference laboratories for specific devices...

Canada Regulatory News, Europe Regulatory News, Ireland Regulatory News, Medical Devices News, UK Regulatory News, USA Regulatory News

EU MDR Regulations

Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of Act (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR

Medical Devices–USA/Europe Regulatory Updates Roundup, Oct 2022

Medical Device

EUROPE MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 The document has been endorsed by the Medical Device Coordination Group (MDCG)...

MHRA Guidance for Medical Device Manufacturers on Vigilance

Medical Device

Adverse incidents involving medical devices that occur in the UK need to be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). Once a medical device has been placed on the...