Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

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Examples of Class III medical devices

Medical Device classification under MDR. Examples of MDR class III medical devices

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Examples of Class IIb medical devices

Medical device classification examples. Class IIb under MDR rules.

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Examples of Class IIa medical devices

Medical device Class IIa examples

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Examples of EU Medical Device - Class I

Examples of medical devices classes

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Impact of extension of the MDR

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the...

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MDR and IVDR Delay!

Today, 6th January 2023, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of...

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EU Health Commissioner proposes MDR delay to prevent medical device shortages

The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years

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Border line products?

#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...

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UKCA Marking - extension of standstill period

The MHRA explained its intention to extend the standstill period of using the CE Mark by 12 months to 30 June 2024 for the medical devices.

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Medical Device User Fee Amendments (MDUFA)

User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the establishment registration fee. There...

UPDATED GUIDANCE MHRA

This guidance document replaces the previous MHRA guidance titled “medical device standalone software, including apps”.

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Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/

Classification of in vitro diagnostic as per Regulation (EU) 2017/746

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Medical Device Labelling Requirements

A label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each...

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CONCLUSIONS FOR A CLINICAL EVALUATION - MDR

A successful clinical investigation for Medical Device Regulation EU 2017/745 (MDR) is one that generates scientifically valid clinical...

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Declaration of conformity for medical devices

The Declaration of Conformity (also known as DoC) is a critical document for every medical device in Europe.