Regulatory Rapporteur

 

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October 2022 | Volume 19 | No.9

EDITORIAL

Great expectations for medical technologies

In this issue, we highlight the challenges faced by the MedTech sector in the context of the new regulations, while also providing insight into how the device regulatory system continues, or should continue, to better meet the sector’s needs.

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By Stephen Dew and Jillian Stewart

FOCUS

Navigating the MDR’s heightened surveillance and performance requirements

The changes introduced by the Medical Device Regulation (MDR) aim to improve patient safety and provide greater transparency. However, interpretation of its requirements has been an issue for many manufacturers. This article explores the changes it brings to the regulatory framework, what they mean, and how best to ensure compliance.

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By Ana Quinn 

FOCUS

EU expert panel for high-risk devices: another level of review?

The new EU regulations for medical devices and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. In 2022, Regulation (EU) 2022/123 gave oversight of these expert panels to the EMA. This article discusses the new level of complexity and criticism this brings into an already strained review process.

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By Colleen Watson and Frances J Richmond

FOCUS

The new UK MDR: a great start to a long road ahead?

On 29 March 2017, the UK began the withdrawal process from the EU. Despite the UK’s departure from the EU on 31 January 2020, EU legislation continues to apply in UK domestic law. As a result, the transition to the EU Regulations for Medical Devices was not completed for Great Britain. This article looks at the UK’s goal for future MDRs in 2023. 

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By Richard Bassett

FOCUS

The importance of subjective and qualitative risk management for medical devices regulation

This article asserts that, in the risk management sector, there is a conflict between the approaches taken by regulators and quality professionals that is preventing the benefits of risk management from being realised.

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By Neil Armstrong

FEATURE

Inclusion of older people in drug development and clinical trials: part 2

The global population is aging but older peopl are an underrepresented cohort in randomised clinical trial design and operation, despite being the main users of medication. In part 2, we analyse whether publication of the ICH E7 Q&A had an impact on the number of older patients included in drug development programmes.

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By Kajal Patel  

FEATURE

The health economics profile of new pharmaceuticals

This article discusses elements of the health economics profile of new pharmaceuticals. It looks at the challenges in providing a healthcare system, the concepts around the provision of value-based healthcare systems, and provides guidance in calculating the cost-effectiveness of new medicines.

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By Chris Wright