+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Technical standards of electromedicals: between old directives and new regulation

One of the characteristics defining the healthcare medical devices is the high impact of technological factors. Regardless the technological level of a medical device, mechanic, electrical, electronic, information elements as well as others are commonly present. This peculiarity has imposed that the legislator takes into account the prescriptive will to fix minimum safety limits and the need not to bind further the freedom of technical and scientific progress at the base of any practical solution that a medical device represents for a specific problem. Such is the impact of this aspect, that article 5 of Directive 93/42/ECC, i.e. the basis of the current regulation framework, has already included the introduction of harmonized norms by which the manufacturers have the possibility to receive (more or less restrictive but technical) requirements on the design characteristics of their medical devices, availing themselves, on the other hand, of a presumption of conformity with the legal essential requirements.

The new Regulation (EU) 2017/745 has not changed the setting based on the use of supporting harmonised norms, it is therefore expected that the impact on technical aspects of medical devices will not be relevant. In fact, it is expected that the inclusion of active implantable medical devices in the Regulation, now separated by Directive 90/385/EEC, will only lead to the inclusion of the corresponding harmonised norms.

Electromedicals refers to harmonised rules of the series CEN EN 60601-X, whose general “ancestor” is norm IEC 60601-1. These norms are now at the third “generation” for their scope of including risk management as early as design phases. This is a requirement imposed not only by European laws on medical devices but also by the other extra-EU countries. Currently the series is divided into three groups: generals, collaterals and particulars. Generals are those norms bound by the application of the general norm but only concerning technical and specific aspects (i.e. norm 60601-1-2 regarding electromagnetic compatibility (emission and immunity) if an electromedical complying with the general norm 60601-1). Particulars are instead those norms regarding specific types of electromedicals (i.e. norm 60601-2-1 regarding electron accelerators). Currently, 48 norms of the series 60601-X result to be harmonised by Directive 93/42/EEC.

Another typical harmonised norm of electromedicals is CEN EN 62304, adopting norm IEC 62304 regarding the management of the whole life cycle of a software. In fact, it is very popular to include programmable electronic systems in electromedicals, as well as real user interface software in the basic design of operational requirements and for data managing.

And as far as the human operational ability of electromedicals is concerned, i.e. the ability of a product “to be used” safely and effectively by a human operator, the use of the harmonized norm CEN EN 62366 in usability engineer of medical devices is more and more diffuse. This adopts the norm IEC 62366 version 2007 now withdrawn because it was replaced by the more recent 2015 version, not yet harmonised. Such dichotomy between the state of the technical art and the legal prescriptions, still starting from technical progress principles as rationale to justify the solutions adopted by manufacturers (see point 2 of Annex I), introduces the second part of this blog dedicated to practical problems of the manufacturers in the application of the law, starting from the well-known issues of the current regulations, up to the novelties introduced by the Regulation entering onto force.

We have seen that there is, and there will always be, a principle of optionality in the use of harmonized norms, and therefore it can be presumed that there will also be as a principle, since it is difficult, in practice, to find notified bodies available to certify electromedicals not complying, and not applying, the essential requirements of 60601-1 and 60601-1-2. Along with it, the regulation also adds the fact that the notified body shall duly consider a harmonised norm applicable to the concerned medical device, even in case the manufacturer does not declare its conformity (Annex VII, point 4, letter d)).

And starting from this second norm, we get to the problem of the concomitant application of more community laws (see Directive 2014/53/EI or Directive 2006/42/EC): just as the current Art.4(5) imposes this on regulations covering different aspects, the same will be done by Art.20(6) of the new Regulation in the future.

And not just this; as now provided for by the annexes on conformity assessment procedures, even in the future, harmonised norms can be applied integrally or partially (Art.8(1)). From this derives that the problem of deciding at what point a harmonised norm is to be applied, including any certification by third bodies, will equally arise in the future. Moreover, there is the aggravating factor of being forced to consider “adequately and promptly” the change of harmonised norms (Art.10(9)). This means that manufacturers shall constantly check that their regularly certified medical devices can still be considered compliant with the Regulation in case of update of the harmonised norm.

Moreover, during the re-certification phase, manufacturers shall be bound to submit a summary of the changes and scientific results regarding the device that shall also include the changes of the new or applied harmonised norms (as effect of Annex VII, point 4.11, letter g)).

Differently from the current regulating framework, where the same CE certification document of a device is not regulated as such, leaving a wide margin of arbitrariness in terms of contents, thus causing a condition close to anarchy, the Regulation specifies the minimum content of the document (Annex XII). Point 10 specifies that it must refer to the tests carried out according to a harmonised norm. It is therefore presumable (and desirable) that it is more transparent and publishes the option of (easily) recognizing the harmonised norms applied by a manufacturer to its own medical device.

Effective control on information transferability that, after all, regard the compliance with the Essential requirements of a medical device, will be more invasive if one considers that manufacturers will be bound to indicate the applied harmonised norms in the new documents on the “synthesis concerning safety and clinical performance” for implantable and class III devices (Art.32, section 2, letter e)).

Last but one comes the issue regarding the familiarity with which the manufacturer must get used to handle the harmonised norms. Today, considering the unpredictability of a harmonised norm, due to undetailed prescriptions, it is often difficult to trace back the activities carried out during the design phase and regarding the application of a harmonised norm compared to its value in demonstrating the compliance with an Essential Requirement. The Regulation introduces the obligation to specify the link between a result from the application of the harmonised norm and the compliance with an Essential Requirement in the technical documentation (Annex II, point 4, letter d)). It follows that, in their practice, manufacturers must handle the use of the harmonised norm consciously, forecasting a prescription of Annex I that is the subject of the compliance demonstration and associating it to each action due to the norm.

The last point concerns clinical trials. So far, as a result of the Italian implementation of article 15 and Annex X of Directive 93/42/EEC, there is no provision obliging manufacturers to submit a full technical documentation to the competent authority authorising the clinical trial, but only to keep it available. A possible result (only in theory, as other measures, especially by the Ministry, decrease its possibility) is that clinical trials are carried out on no CE-marked medical devices without full supporting technical documentation. On the contrary, Regulation (Art.71(3)) shall oblige the competent authority to duly take in account even the harmonised norms applicable in the demonstration of the compliance with the safety and performance requirements in their assessment process of the clinical trial project (except, of course, for the aspects concerned by the clinical trial itself). This implies that manufacturers proposing a clinical trial will have to have already prepared and completed the technical documentation (as far as applicable), regardless the device risk class.

The conclusion is that the current regulating framework has already developed procedures to use harmonised norms, which the new Regulation will not change in the essentials, leaving the current manufacturers’ practical problems unvaried. On the contrary, although the impact on the design technical aspects is going to be marginal for the complying manufacturers compared to other provisions, the unaware or no forward-looking use of harmonised norms can seriously compromised the device marketing plan for unprepared manufacturers.