New regulatory framework for medical devices made of substances

Written by Luisa Antunes with Laia Delgado Callico.

Substance-based medical devices (SBMD) are health products with physicochemical properties and without a pharmacological, immunological or metabolic mode of action – such as nasal and eye sprays, cough syrups, hand and vaginal creams, and toothpaste. To ensure these devices are safe to use, they were recently placed under new classification rules by the EU Medical Devices Regulation (Regulation (EU) 2017/745), which applies from May 2021.

To discuss this new regulatory framework and present current research on non-pharmacological health products, the European Parliament’s Panel for the Future of Science and Technology (STOA) organised a hybrid workshop ‘Medical devices made of substances: Opportunities and challenges‘, which took place on 16 November 2021.

Member of the European Parliament and STOA Panel member Patrizia Toia (S&D, Italy), opened the workshop, highlighting the importance of understanding the definition of SBMD and how to differentiate them from pharmacological products, as well as discussing ‘orphan devices’ – those which do not fall under any legislation. Paul Piscoi, Policy Officer with the Directorate-General for Health and Food Safety (DG SANTE) at the European Commission moderated the event.

Panel 1 – The science of substance-based medical devices

Three presentations discussed the science of SBMD. Marco Racchi, Professor of Pharmacology at the University of Pavia (Italy), focused on the importance of carefully defining the concept of non-pharmacological modes of action, and its distinction from therapeutic effect. A substance with a therapeutic effect is either a medicinal product or a medical device, depending on its mechanism of action. However, SBMD often have more than one mechanism of action concurring to the claimed therapeutic effect. Natural substances are composed of a very high number of molecules acting in synchrony and are best represented by the concept of ‘system’, something that is more than the sum of its components.

Annamaria Staiano, Professor of Pediatrics at the University Federico II, Napoli (Italy), highlighted the role of natural complex substances in paediatrics. Both structural and functional interactions can occur between the many natural substances contained in a therapeutic product. Professor Staiano presented the results of a clinical study using a medical device made of 100 % natural substances. It demonstrated a safe and effective clinical response, comparable to the standard of care and with at least equally high benefit-to-risk ratio.

Peter Malfertheiner, Professor of Medicine at the University Hospital Ludwig Maximilian University (LMU) in Munich (Germany), discussed SBMD in the management of patients with gastrointestinal diseases. Professor Malfertheiner provided two examples of how natural substances can treat gastroesophageal reflux disease and metabolic syndrome. Current pharmacological management of patients with metabolic dysfunctions does not offer alternatives to the administration of as many drugs as the number of different metabolic disorders. Here, SBMD are a highly effective therapeutic option, a valid alternative to synthetic drugs, and complementary in certain conditions to conventional pharmacological therapies.

Panel 2 – Regulatory aspects of substance-based medical devices

The second panel focused on the regulatory aspects of SBMD. Olga Tkachenko, Policy Officer with DG SANTE at the European Commission, gave an overview of the new rules for SBMD defined by the Medical Devices Regulation. The new regulatory framework provides higher standards of evidence, more transparency and traceability, and greater alignment among actors, whilst also considering technological progress, such as cybersecurity and sales over the internet. Furthermore, the new rules serve to ensure the safety and performance of these devices, through appropriate risk classification and assessment procedures. The guidance documents issued by the Medical Device Coordination Group and guidance on therapeutics which are positioned on the borderline with medicines, which is currently under revision, will assist in the aligned application of these new rules.

Oliver Hartmann, Legal and Regulatory Affairs Manager at the Association of the European Self-Care Industry (AESGP), discussed the industry perspectives on a fit-for-purpose regulatory framework for SBMD. The first step in the assessment of an SBMD, as a borderline product, is to confirm its regulatory status and risk classification, by using proportionality and a case-by-case assessment. Clear and workable definitions of pharmacological, immunological and metabolic means are required: to apply the SBMD regulation; to distinguish SBMD from medicinal products; and to avoid an indirect, extended scope of the definitions, rendering a product category ineffective. Regulators require expertise in assessing the physical or mechanical mode of action together with knowledge of classification criteria and different legal definitions.

Emiliano Giovagnoni, Innovation and Medical Science Director at Aboca (Italy), focused on the opportunities for innovation in healthcare offered by SBMD. The new regulation increases the level of evidence needed to demonstrate the safety and the efficacy of SBMD following an evidence-based medical approach. The therapeutic properties of SBMD can be identified by describing their mechanisms of action in a scientific, but non-pharmacological, approach using biological sciences. Strengthening the post-marketing surveillance introduced by the regulation allows real-world evidence data to be collected to ensure a continuous reassessment of the efficacy and safety of products, even after placement on the market. The major challenge of implementation is defining pharmacological means and borderline products, particularly herbal products. While Chapter 1.2.4.4. of MEDDEV 2.1/3 Rev. 3 is dedicated to setting classification criteria for products containing ‘medicinal plants’, the criteria proposed to distinguish between a drug or a medical device do not follow a case-by-case approach. A revision of the framework for traditional herbal medicinal products is therefore required.

Member of the European Parliament Simona Bonafè (S&D, Italy) closed the workshop, noting that the approval of the regulation was a major step forward for the European health system and demonstrated the European political will to recognise the important role that SBMD play in the prevention and treatment of diseases. Within the Green Deal framework, Simona Bonafè emphasised that natural complex substances have a lower impact on the environment since they are 100 % biodegradable.

The full recording of the workshop is available here.

Your opinion counts for us. To let us know what you think, get in touch via stoa@europarl.europa.eu.