Regulatorische Updates

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Sep 30 , 2020

An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use

Analysis of FDA's proposed new definition of Intended Use concepts pertaining to medical devices and drugs, and recommendations for how manufacturers can prepare for possible changes.

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Sep 29 , 2020

2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering

Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.

Sep 22 , 2020

Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs

Fast-track Japan PMDA registration now open for qualifying medical device and IVD manufacturers as PMD Act revisions begin taking effect.

Sep 15 , 2020

US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility

Final FDA guidance on ISO 10993-1 for biological evaluation of medical devices gets an update. Learn more about US medical device regulations at Emergo by UL.

Sep 3 , 2020

UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain

Aug 19 , 2020

Updated European UDI FAQ Features Revised Compliance Deadlines

The European Commission has published a guide featuring complete timetables that incorporate recent regulatory postponements.

Aug 18 , 2020

Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

Considerations for medical device manufacturers ahead of MDR compliance for ensuring adequate clinical data management, including post-market clinical follow-up (PMCF) activities.

Aug 11 , 2020

US FDA Medical Device User Fees Increase 7% for 2021

FDA user fees for the agency's 2021 fiscal year increase by seven percent, including for small-business applicants. Learn more about US FDA regulatory issues at Emergo by UL.

Jul 21 , 2020

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

New legislation is being rolled out in stages to match changing European regulations and prepare the ground for a mutual recognition agreement.

Jul 21 , 2020

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.

Jul 10 , 2020

US FDA Extends UDI Deadlines for Low-risk Medical Devices

FDA focusing on coronavirus pandemic response, UDI implementation for higher-risk medical devices. Learn more about Unique Device Identification regulations at Emergo by UL.

Jun 16 , 2020

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards

Regulatorische Updates

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An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use

2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering

Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs

US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility

UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance

Updated European UDI FAQ Features Revised Compliance Deadlines

Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

US FDA Medical Device User Fees Increase 7% for 2021

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

US FDA Extends UDI Deadlines for Low-risk Medical Devices

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

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Regulatorische Updates

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An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use

2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering

Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs

US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility

UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance

Updated European UDI FAQ Features Revised Compliance Deadlines

Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

US FDA Medical Device User Fees Increase 7% for 2021

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

US FDA Extends UDI Deadlines for Low-risk Medical Devices

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

Fordern Sie Informationen von unseren Experten an

Vielen Dank! Wir haben Ihre Anfrage erhalten.