Medical Device Blog

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

Soledad

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...

Soledad

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

Soledad

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.

Soledad

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”.

Soledad

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.