Medical Devices White Papers

Our white papers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. Please complete the fields below to access all of our medical device white papers.

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EU MDR and IVDR: unique device identification

EU MDR and IVDR: unique device identification

This white paper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.

Phthalates and endocrine disruptors

Phthalates and endocrine disruptors

Phthalates are plasticizers that impart flexibility to plastic products and can leach into their surroundings. Many phthalates have the potential to cause hormonal disruption. This white paper summarizes the evaluation of phthalates and endocrine-disrupting (ED) substances in medical devices (MDs).

The convergence of the pharmaceutical and medical devices industries

The convergence of the pharmaceutical and medical devices industries

Find out more about the different categories of combination products within the EU along with the regulatory pathways designed to ensure they are safe and perform as intended.

Person responsible for regulatory compliance (PRRC)

Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15

With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements.

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Software as a medical device

Software as a medical device - A comparison of the EU’s approach with the US’s approach

The International Medical Device Regulators Forum (IMDRF) aims to accelerate international medical device regulatory convergence.​ Through the IMDRF, regulators reached consensus on what software is considered a medical device. Regulators call it ‘software as a medical device’ (SaMD). This paper provides a comparison of how SaMD is regulated in the US and in the EU.

Medical device clinical investigations – What’s new under the MDR

Medical device clinical investigations – What’s new under the MDR?

The conduct of a clinical investigation is one of the most time consuming and resource intensive activities that a medical device manufacturer can face. This paper discusses important new requirements for pre-market and post-market clinical investigations under the European MDR.

Machine learning AI in medical devices

Machine learning AI in medical devices

How is AI different from traditional medical devices and medical software and what are the implications of those differences? What controls are necessary to ensure AI in healthcare is safe and effective?

Sterilization – Regulatory requirements and supporting standards

Sterilization – Regulatory requirements and supporting standards

Regulatory requirements for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements have been supported by a portfolio of standards.