Delving into EU MDR

Delving into EU MDR

Featured on Delving into EU MDR

Medical Device Regulations

Is EU MDR Worth the Hassle and Expense?Is EU MDR Worth the Hassle and Expense?

An expert takes MD+DI through the challenges, pros and cons, and strategies for a smoother European medical device approval process.

byLisette Hilton, Reporter and President

Aug 8, 2024

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6 Min Read

Regulatory & Quality

EU MDR Poses Challenges for Manufacturers EU MDR Poses Challenges for Manufacturers

byBob Kronemyer

Jun 3, 2024

4 Min Read

Peter Wirthschaft, PhD, senior manager, medical device/IVD consultant for global public health and safety organization NSF

Regulatory & Quality

Seeing Double: What to Watch When Bringing Combination Products to the EU Market Seeing Double: What to Watch When Bringing Combination Products to the EU Market

byHeather R. Johnson

May 23, 2024

5 Min Read

Graphic featuring a headshot of MD+DI Senior Editor Amanda Pedersen and pull quote from her Pedersen's POV opinion column.

Medical Device Regulations

EU MDR: Something's Gotta Give EU MDR: Something's Gotta Give

byAmanda Pedersen

Feb 5, 2024

4 Min Read

Concept illustration of the European Union Medical Device Regulation

Medical Device Regulations

When Will the EU MDR Burden Begin to Ease?When Will the EU MDR Burden Begin to Ease?

byHeather R. Johnson

Jan 29, 2024

7 Min Read

Medical Device Regulations

Getting a Handle on EU MDR Getting a Handle on EU MDR

byHeather R. Johnson

Nov 20, 2023

4 Min Read

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Telesair's Bonhawa High Flow Oxygen Therapy System

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EU MDR Is the New FDA PMA

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Traceability Requirements in EU MDR

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A Few New Challenges with EU MDR

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A Few New Challenges with EU MDR

A Few New Challenges with EU MDR