MDR & IVDR
Over 500,000 types of medical devices (MDs) are now covered by the European Union (EU) Medical Device Regulation (MDR) 2017/745, varying from contact lenses, x-ray machines, pacemakers, breast implants, hip replacements and plasters.1 This legislation is complemented by the In Vitro Diagnostic Regulation (IVDR) 2017/746, applying to IVDs for human use and their accessories, which are used to perform tests on samples like HIV blood tests, pregnancy tests, and blood sugar monitoring systems for diabetics.2
MDR and IVDR increase transparency and bring the EU legislation in line with technological advances, but they also bring tighter controls. There is now a need for strong clinical evidence through the implementation of clinical trials to achieve certification and market approval by a Notified Body (NB).
Compliance with the General Safety and Performance Requirements (GSPR)
The quantity and quality of the clinical evidence needed for certification must be sufficient to demonstrate safety, performance and the acceptability of the benefit-risk ratio of a device according to the General Safety and Performance Requirements (GSPR), a set of technical requirements that products must meet to be certified as safe and compliant.3So, whether a medical product is novel, a legacy, or has no medical purpose, it still needs to provide sufficient clinical evidence according to its intended purpose, target group, indication, contraindication, intended clinical benefits if any, and fitting to the relevant specified clinical outcome parameters.4
MD clinical investigations: ISO 14155:2020
Clinical investigations of medical devices for human subjects need to be performed according to good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects. ISO 14155:2020 applies to all MD clinical investigations emphasizing risk management principles throughout the entire MD clinical investigation process. It focus on protecting the rights, safety and well-being of the individuals; ensuring the scientific conduct and credibility of the results; defining the responsibilities of the sponsor and principal investigators; and assisting all parties, including ethics committees and regulatory authorities, involved in the conformity assessment of MDs. 5
IVD MD clinical performance studies: ISO 20916:2019
In relation to IVDs, clinical performance studies must be performed according to ISO 20916:2019, which defines good study practice (GSP) for the planning, design, conduct and reporting of the clinical study in order to assess the clinical performance and safety of IVDs for regulatory purposes. Such studies assess the ability of an IVD MD to yield results pertaining to a particular medical condition or physiological/pathological state in the intended population in the hands of the projected user.6
IVD & MD mix
In a situation for which there is an IVD medical product, and a MD used in an integrated system (e.g., a lancet, IVD test strip, or a glucose meter), aspects of both ISO 20916:2019 and ISO 14155:2020 can be considered to gather the proper clinical evidence.
Strategy for novel devices
It is important to develop a robust clinical strategy earlier in a product’s lifecycle (early-stage lifecycle management) to generate a sustained progression of data throughout the brand’s lifetime.
What about a strategy for legacy or WET devices?
In the case of legacy and Well Established Technologies (WET), a gap and competitor analysis can help devise what really drives treatment decisions and what new data would be viewed as clinically meaningful for prescribers and value-creating for economic stakeholders. Doing this well requires a rigorous analysis, including assessment of the critical drivers of behaviour for each stakeholder, stakeholder perception mapping, detailed comparison of competitor labels and clinical data, and a granular understanding of real-world data on treatment decisions and outcomes. Such gap and competitor analysis can help identify unmet needs, that if suddenly met would drive real change in stakeholder behaviour. Detailed comparison of competitor labels and clinical data uses competitive intelligence to further inform which clinical efficacy and safety endpoints matter most. The combination of such analyses allows the identification of what drives stakeholder behaviour, how competitors stack up against those factors, and what degree of improvement would be required in future trials to represent true clinical value.
Developing a robust clinical strategy will drive lifetime value. It will impact regulatory approval, the level of reimbursement, the willingness of prescribers to change their behaviour and the ability to differentiate your medical product against incumbent and future competitors.
by Catarina Carrão
(aka Ana Catarina Ribeiro Carrão)
All references assessed 6th November 2023.