by Fabrizio Gozzi | Head of Machine Safety at Om.En.
Directive 93/42/EEC as amended, which will be replaced by Regulation 745/2017 from 26 May 2021, indicates as a medical device: 'any instrument, apparatus, implant, software, substance or other product, whether used alone or in combination, including software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes...' . This definition, which is quite complex, immediately highlights the complexity of the subject. Manufacturers of such devices have to juggle a very wide field, ranging from simple surgical masks, so much used because of the Covid-19 emergency, to very complex equipment, such as MRI equipment. Furthermore, for these devices, it is necessary to clearly indicate what their correct use is, otherwise the CE marking will not be valid for that particular application.
Application of the Directive
For all medical devices, Directive 93/42/EEC sets out the 'Essential Safety Requirements' that devices must meet. Obviously, the response to these requirements will be very different, depending on the device. In order to help the manufacturer adopt the best technical solutions for design and manufacture, the European community has issued EU Regulation 1025/2012, which establishes so-called "harmonised" technical standards which, if met, give presumption of conformity with the requirements of the relevant directive. Obviously, medical device manufacturers tend to comply with these standards, also encouraged by Notified Bodies, in order to ensure the safety of their products and to simplify their work of certification and CE marking.
In this very particular phase, where medical devices such as masks have become commonly used, on 3 April 2020 the European Commission issued a specific guidance "Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context", which helps manufacturers in the application of the directive.
In particular, for manufacturers and importers, the document in Annex 1 contains the most relevant European harmonised standards for a number of Medical Devices such as masks, gloves, ventilators, tracheostomy tubes, respiratory therapy equipment, medical device manufacturing etc.
Legal status
The emergency also forced the large-scale importation of all devices that were not available on the European domestic market. For this reason, in order to protect the population, the guideline contains a table, in Annex 2 (and available on the European Community website), comparing the different international standards within the legal systems of the member countries of the International Medical Device Regulators Forum. Thanks to this table, it is possible to quickly compare the legal status of European standards with standards in Australia, Brazil, Canada, China, Japan, Russia, Singapore, South Korea and the USA. In addition, access to technical standards considered relevant for medical devices, in relation to growing market demand, has been made free of charge on the websites of the national standardisation bodies. In Italy, in fact, all standards considered important due to this emergency can be downloaded directly from the website of thenational standardisation bodies.Uni.
The case of ozonators
What should a manufacturer do when producing a device that is not a standardised device? Manufacturers and importers may find themselves in the situation of having to CE mark a particular device, which is required by the market but does not have a specific regulation to which to refer in order to meet the requirements of Directive 93/42/EC. In addition, doubts may arise as to whether the Directive is actually applied. For example, there are devices on the market known as 'ozonators' which promise to sanitise entire rooms and their contents. But is this really the case? In this situation we must appeal to our common sense and to all the indications published by the competent bodies. Ozone generated in situ from oxygen is an active ingredient with a "biocidal" action as a disinfectant for surfaces, drinking water and for use in the cooling towers of industrial plants.
Although the evaluation has not been completed, a large database is available that confirms its microbicidal efficacy even on viruses. Marketing in Italy as a 'disinfectant' is not permitted at this stage, so ozone can be considered a 'sanitiser'. The use of ozone is currently permitted internationally in food, surface sanitation and drinking water.
This information is clearly indicated in the ISS Covid-19 Report no. 25/2020 "Interim recommendations on the sanitation of non-health facilities in the current Covid -19 emergency: surfaces, indoor environments and clothing". Furthermore, also on the same report, it is stated that: "There is no technical scientific evaluation today that attests to the effectiveness against Covid -19 of the virucidal action of ozone following ozonation as for many other products used in disinfection (e.g. UV rays)".
Having said this, it is therefore illegitimate to include in the intended use the ability of the device to prevent Covid -19 from infection or to declare its effectiveness in terms of virucidal action; the possibility of identifying the product as a medical device therefore lapses.
The ozonator, therefore, intended as a system for disinfecting environments, must no longer comply with the Medical Devices Directive, but with the Low Voltage Directive (Directive 2014/35/EC), Electromagnetic Compatibility Directive (Directive 2014/30/EC) and possibly the Machinery Directive (Directive 2006/42/EC) if equipped with a mobile device. Basically, it must be identified as a simple room sanitiser without specific relevance to Covid-19 infection prevention and without being declared a medical device. The certification procedure does not change, as compliance with the requirements of the applicable European directives must in any case be guaranteed, but it clearly varies in content.
