Language Scientific Outlines What “Quality” Means in Medical Device Labeling Translation

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
MD&M East

Medical Device Reporting: A Risk-Management Approach

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...
MedTech Intelligence

The Risk of Using a Device Off-Label Versus Contraindicated

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
HealthTech

MDR Medical Device Regulations: A Safety Net or Too Much Restriction?

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
JD Supra

Medical Devices in the EU: MDD Certificates Remain Valid - the EU Extends Transition Periods for MDR Compliance, and Sell-Off Dates for Devices Under MDD and IVDD Fall Away!

Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional ...
Business Wire

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation 2017/745) and IVDR (In-Vitro Diagnostic Regulation 2017/746 ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...
MD&M East

Getting a Handle on EU MDR

Traditionally, if medical device manufacturers wanted to get products into a major market quick, they obtained CE Marking in the European Union first. The EU required proof of safety and performance, ...