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A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation
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A Notified Body’s perspectives on progress made in transitioning combination products to the MDR
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An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure
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An overview of the medical device regulations in Jordan
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An overview of the medical device regulations in the Islamic Republic of Iran
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An overview of the medical device regulations in the Kingdom of Saudi Arabia
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An overview of the regulatory requirements for medical devices and IVDs in Botswana
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An overview of the regulatory requirements for medical devices and IVDs in Uganda
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An overview of the regulatory requirements for medical devices in Colombia
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An overview of the regulatory requirements for medical devices in the Republic of Korea
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An overview of the regulatory requirements for medical devices in Tunisia
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An updated overview of the regulatory requirements for medical devices, including IVDs, in Cuba
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Analysis of the European Commission’s proposal for the revision of the MDR and IVDR
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August 2019 – Volume 16, Issue 3
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August 2020 – Volume 17, Issue 3
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August 2021 – Volume 18, Issue 3
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August 2022 – Volume 19, Issue 3
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August 2023 – Volume 20, Issue 3
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August 2024 – Volume 21, Issue 3
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August 2025 – Volume 22, Issue 3
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Best practices for medical device cybersecurity planning from a US perspective
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Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program
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Canadian regulatory framework for software-based medical devices and emerging technologies
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Clarifying the role of equivalence and similarity in medical device conformity assessment under the MDR
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Clinical data and the federated learning concept for an AI/ML device
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Considerations for designing and implementing successful PMCF surveys
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Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design
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Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications
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EUDAMED: Important considerations for ensuring preparedness and compliance
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Event Calendar advert on GRP website (15-04-2024 to 15-06-2024)
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A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation

A Notified Body’s perspectives on progress made in transitioning combination products to the MDR

An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure

An overview of the medical device regulations in Jordan

An overview of the medical device regulations in the Islamic Republic of Iran

An overview of the medical device regulations in the Kingdom of Saudi Arabia

An overview of the regulatory requirements for medical devices and IVDs in Botswana

An overview of the regulatory requirements for medical devices and IVDs in Uganda

An overview of the regulatory requirements for medical devices in Colombia

An overview of the regulatory requirements for medical devices in the Republic of Korea

An overview of the regulatory requirements for medical devices in Tunisia

An updated overview of the regulatory requirements for medical devices, including IVDs, in Cuba

Analysis of the European Commission’s proposal for the revision of the MDR and IVDR

August 2019 – Volume 16, Issue 3

August 2020 – Volume 17, Issue 3

August 2021 – Volume 18, Issue 3

August 2022 – Volume 19, Issue 3

August 2023 – Volume 20, Issue 3

August 2024 – Volume 21, Issue 3

August 2025 – Volume 22, Issue 3

Best practices for medical device cybersecurity planning from a US perspective

Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program

Canadian regulatory framework for software-based medical devices and emerging technologies

Clarifying the role of equivalence and similarity in medical device conformity assessment under the MDR

Clinical data and the federated learning concept for an AI/ML device

Considerations for designing and implementing successful PMCF surveys

Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design

Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications

EUDAMED: Important considerations for ensuring preparedness and compliance

Event Calendar advert on GRP website (15-04-2024 to 15-06-2024)