Medical Device Blog

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

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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...

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FDA NEWS: Electronic Submission Template for Medical Device 510(k) Submissions

This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s.

UPDATED GUIDANCE MHRA

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

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FDA allows access to over-the-counter hearing aids

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Medical Device Regulation for non-medical products

Medical devices without an intended medical purpose (non-medical products) that fall under the Medical Device Regulation 2017/745.

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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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Diagnostics consultation procedure to the European Medicines Agency - When IVD gets involved

Diagnostics consultation procedure to the European Medicines Agency - When IVD gets involved - companion diagnostics consultation

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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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MDCG 2022-9 Summary of safety and performance Template

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of...

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MDSAP AUDIT APPROACH

Maybe you are looking to be into the MDSAP program and to benefit for it. We want to provide you the latest guidance on the MDSAP Audit...

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Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745

Check the final guidance from the MDCG. This document provides further explanations and examples clarifying these provisions in order to...

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EU-TURKEY CUSTOMS UNION AGREEMENT IN THE FIELD OF MEDICAL DEVICES

“Whenever the EU instrument listed above [i.e. Regulations 2017/745 or 2017/746] and the relevant Turkish provisions giving effect to...

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REGULATION (EU) 2022/112 - Updates to the In Vitro Diagnostic Medical Devices Regulation

The amendments made to the IVDR transitional provisions do not postpone the IVDR’s entry into application on 26 May 2022. This is...

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The little updating of notified body under IVDR, judges its implementation

The European Commission's update reveals a growing pipeline of submissions approaching MDR designation, but little hope for a short-term...

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What a United Kingdom Responsible Person (UKRP) does?

After December 31, 2020, after the United Kingdom left the European Union, the United Kingdom faced a new regulatory situation. It has...

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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...