The MDR’s increased requirements for clinical evaluations of medical devices – A step in the right direction?

The Medical Device Regulation (EU) 2017/745 (MDR) has changed the medical device industry and set new standards for the safety, quality and development of medical devices. In particular, the increased requirements for clinical evaluations are intended to be an important step towards monitoring the safety and performance of medical devices more effectively and increasing confidence in these products. In this first article of our series "Clinical development of medical devices", you will get a comprehensive overview of the background and objectives of the MDR and the new requirements for the clinical evaluation of medical devices.

The introduction of the MDR in May 2017 marked the beginning of a new era in the regulation of medical devices. It replaces the previous Medical Device Directive 93/42/EEC (MDD) and represents a significant change in medical device legislation. A key aspect of the MDR is to ensure a more thorough and comprehensive assessment of the safety and performance of medical devices in the European Union (EU), while improving the safety of patients and users.

Background: Scandals and warning letters lead to stricter regulations!

A major impetus for the introduction of the MDR were numerous scandals and shortcomings that were uncovered in the medical device industry. An exemplary scandal was triggered by the French company Poly Implant Prothèse (PIP), which used non-medical industrial silicone in its breast implants, causing worldwide outrage. It demonstrated the urgent need for stricter monitoring of medical devices to minimise the risk of misproduction, misuse and potential harm to patients and users. More intensive surveillance should additionally ensure that products continue to meet the general safety and performance requirements and can be used safely.

Increased requirements: More comprehensive clinical evaluations and evidence of clinical safety and performance required!

Clinical evaluation is a systematic and planned process for the continuous generation, collection, analysis and assessment of clinical data. It is used to evaluate the safety and performance, including clinical benefit, of a device, taking into account the use intended by the manufacturer (according to Article 2 (44), MDR).

The increased requirements relate to various aspects of clinical evaluations. Some of the most important requirements are:

• Increased requirements for clinical data: The MDR imposes stricter requirements on the clinical data needed to assess the safety and performance of a medical device. Manufacturers are expected to submit more comprehensive and higher quality clinical data, including clinical trial data, to demonstrate performance and safety of the device.
• Clinical evaluation strategy: The manufacturer must develop a comprehensive clinical evaluation strategy that describes the selection and evaluation of relevant clinical data to support the conformity of the device with the general safety and performance requirements of the MDR.
• Consideration of the equivalence strategy: If equivalence is claimed to a product already on the market, the manufacturer must perform equivalence on the basis of technical, biological and clinical characteristics. It must be clearly demonstrated that the manufacturer has sufficient access to the data of the medical devices for which equivalence is claimed. Furthermore, the MDR sets additional requirements for medical devices of certain risk classes. For example, manufacturers of class III devices and implantable devices are required to conclude a contract wit the manufacturer of the second device that explicitly allows access to the technical documentation.
• Greater focus on clinical investigations: The MDR contains a greater level of detail than the MDD, which is due to the implementation of aspects related to Good Clinical Practice (GCP), many of which were previously in the form of guidelines and standard documents. For certain clinical investigations, the sponsor will still need to review and comply with specific national regulations that may be applicable.
• More rigorous review of Clinical Evaluation Reports (CERs) and study-specific documentation by Notified Bodies: Notified Bodies will now more carefully review the clinical evaluation and related documentation submitted by the manufacturer to ensure that the requirements of the MDR are met. For example, the assessment of the appropriateness of using data from potentially equivalent devices is carried out taking into account factors such as new indications and innovations. For each feature of the device that is claimed by the manufacturer to be innovative or for new indications, the Notified Body has to assess the extent to which specific claims are supported by preclinical and clinical data and risk analysis.

TentaConsult - your strong partner for clinical evaluations under the MDR!

The tightening of requirements for clinical evaluations is undoubtedly a significant change to demonstrate the safety and performance of medical devices. However, this means that medical device manufacturers will have to invest significantly more time, effort and know-how in evaluating their products. Nevertheless, this is crucial to demonstrably confirm the safety and performance of medical devices.

As a competent partner and expert in the field of clinical evaluation and strategic product development, TentaConsult Pharma & Med GmbH supports its clients. We support you in meeting the requirements of the MDR and in conducting a successful clinical evaluation.

Feel free to contact us for further information and support!

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