Following four years of complicated negotiations that began within the Council of the European Union in October 2012, on 17 June the European Parliament finally published the new Regulations that will replace the Directives on medical devices, active implantable medical devices and in vitro diagnostic medical devices. As this is a Regulation and not a Directive, it is not necessary for each Member State to transpose the regulatory text. This will prevent each Member State ... Following four years of complicated negotiations that began within the Council of the European Union in October 2012, on 17 June the European Parliament finally published the new Regulations that will replace the Directives on medical devices, active implantable medical devices and in vitro diagnostic medical devices. As this is a Regulation and not a Directive, it is not necessary for each Member State to transpose the regulatory text. This will prevent each Member State from applying its own interpretation of the Regulation, as has been the case to date. The new Regulations will affect more than 500,000 devices, including sticking plasters, plaster casts, diagnostic tests and pacemakers and will affect a market that, according to Council of Europe data, generates almost one hundred billion euros within the European Union. The purpose of the new Regulations is to provide greater safety and transparency for patients, increase the cross border traceability of devices and update the previous regulations governing this area, which dated from the 1990s. In point of fact, the desire to review legislation to increase safety arose following the PIP breast implant scandal, in which industrial silicone was used in implants, leading to serious health concerns for individuals worldwide. It is common knowledge that publishing these Regulations has been a long and costly process, as 260 amendments were made to them following the European Parliament's vote on the issue in April 2014. The Regulations are not expected to be approved until the end of the year, when they will be sanctioned by the European Parliament and published in the Official Journal. Thereafter, the Regulation on medical devices will not enter effect until 2019, while the Regulation on in vitro medical devices will not enter effect until 2021. Notwithstanding the above, it is expected that the text published by the European Commission on 17 June will be largely retained. Based on a preliminary analysis of the Regulation on medical devices, which is the focus of this text, our first impressions of some of the new items introduced are as follows: A WIDER DEFINITION OF MEDICAL DEVICES: The new Regulation on medical devices extends the definition of the concept of medical devices to include not only devices used to diagnose, prevent, monitor, treat or alleviate an illness, but also those used in the forecasting or prognosis of illnesses. As such, all software and APPs designed for any of the purposes included in the definition of medical devices, including those used in the forecasting or prognosis of diseases, shall be considered medical devices. It must be noted that the Regulation specifies that general purpose software shall not be considered a medical device, even if it is used in a healthcare context. Likewise, lifestyle or wellbeing software shall also not be considered a medical device. This amendment could also have a significant impact on the healthcare services field, as the Regulation stipulates that devices that are not placed on the market but used within a business context (for a fee or free of charge) and offered via the Internet (either directly or indirectly to individuals within the EU) must comply with it. As such, the Regulation is intended to clarify circumstances in which companies outside of the European Union provide disease diagnosis or prognosis services through the provision of analysis services by sending extraction kits to patients' homes. Under the new Regulation, these services will also be considered medical devices. GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE THAT ARE ALSO INCLUDED: In addition to the above, the new Regulation is broader in scope as it applies to medical devices, their accessories, and groups of products without an intended medical purpose, such as contact lenses, substances or items created for facial or dermatological use by means of injection or another type of introduction (excluding tattoos) and high intensity electromagnetic radiation equipment for use on the body, as used in depilation and tattoo removal treatments. The Regulation considers that these types of products with an aesthetic rather than a medical purpose may be similar to medical devices in terms of functionality and risk profile, and as such must be considered medical devices. Furthermore, pursuant to the Regulation, these types of products must comply with requirements that apply to those with both a medical and non-medical purpose. COMPETENCE OF THE EUROPEAN COMMISSION TO CATEGORISE: One of the most important developments of the new Regulation relates to the European Commission's competence to categorise and classify devices. Article 3 of the Regulation on Medical Devices provides that at the request of Member States or at its own initiative, the European Commission may determine, after consulting with the Medical Device Coordination Group (MDCG), whether or not a specific device should be classified as a medical device or as an accessory to a medical device. The Regulation prescribes that the European Commission must share its expertise in the fields of medical devices, medicines, human tissues, cosmetics, biocides, food and any other type of product with Member States. The Regulation also prescribes that the European Medicines Agency (EMA), European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA) be consulted, where applicable, in order to discuss the status of these types of products. To date and in accordance with Directive 93/42/EEC of 14 June, Member States are responsible for clarifying which categories certain products belong to. To date in Spain, Royal Decree 1591/2009 on health products empowers the Spanish Agency for Medicines and Medical Devices (AEMPS) to decide how to apply the definitions of medical devices, accessories, in vitro diagnostic medical devices, customised devices or clinical research devices. However, in the event the AEMPS considers that a decision is needed about whether or not one of the aforementioned definitions applies to a device or group of devices, it will submit a duly justified request to the European Commission in order that it may adopt the necessary measures. The change introduced by the new Regulation will require manufacturers of medical devices to invest more time into deciphering what category a product falls into, which might be seen as hampering the speed of the procedure. Furthermore, it is not yet known how this new reality will be implemented, which could give rise to the Commission making decisions that contradict the criteria applied by Member States. NEW OBLIGATIONS FOR ALL: The new Regulation will add to the obligations of all operators within the medical device market, as it will impose new obligations on manufacturers, importers, distributers and authorised representatives. One of the many obligations imposed on manufacturers is the requirement to possess the new Unique Device Identification (UDI) system that improves the traceability of medical devices, post-sales monitoring of devices, application of corrective measures and healthcare authority monitoring activities. The Unique Device Identification system issues a specific device identifier for each manufacturer and device (device identifier, DI) and a production identifier that identifies data related to the unit of device production (production identifier, PI). This system, by which the level of traceability of medical devices can be increased via the supply chain, will improve safety, as it will enable medical devices that may present risks to be quickly and efficiently withdrawn and will also help in the fight against counterfeit devices. However, implementing such a system will prove extremely expensive for medical device manufacturers, as it will require thorough and detailed monitoring of medical devices, which will be demanding for manufacturers. We believe, in order to simplify the system, it would have been sufficient to issue just one UDI per batch of devices, or even to not implement such a demanding mechanism for low-risk medical devices. Nonetheless, it is true that the implemented system does ensure traceability and enable devices to be quickly withdrawn should any incident occur or impairment be identified. Under the current system, this is sometimes difficult to do. Another obligation the Regulation imposes on manufacturers is the requirement to take out an insurance policy to cover potential liabilities that could arise from a defective device. Although manufacturers already hold these types of insurance policies, the Regulation stipulates as a legal obligation that such insurance policies must be acquired, and that they must be appropriate in terms of product type, class and risk. OBLIGATION TO ENGAGE A COMPLIANCE MANAGER: Another feature of the new Regulation is the requirement for a regulatory compliance manager. Manufacturers must have at least one individual responsible for ensuring regulatory compliance within their organisation. Said individual must have proven experience in the field of medical devices. It is not a requirement for micro and small businesses to employ a regulatory compliance manager within their organisation. However, they must have access to such an individual at all times. This requirement for expertise must be evidenced by means of a university degree in law, medicine, pharmacy, engineering or another scientific discipline and one year of professional experience, or four years of experience in the regulatory field or in medical device systems management. It is not a requirement for the authorised representatives of manufacturers to employ regulatory compliance managers within their organisation; however, they must have access to such an individual at all times. IMPLANT CARD: A new measure that affects patient safety is the requirement for manufacturers of implantable devices to provide patients with an implant card that must contain the name of the device, serial number, batch code, UDI, device model and relevant warnings, precautions and information about the useful life of the implant. This information must be made available to patients in such a way so as to ensure it can be accessed quickly and understood. Information must be updated on the manufacturer's website on an ongoing basis. Certain specific types of implants do not require this level of information. These include sutures, staples, dental implants and dental appliances. MEDICAL DEVICE COORDINATION GROUP: Another innovation introduced by the Regulation is the creation of the Medical Device Coordination Group (Article 78), which is comprised of one expert per each Member State whose duty (among others) will be to advise the European Commission, assist the competent authorities of Member States, and contribute to developing standards. This reform coincides with the creation of the Committee on Medical Devices of the Spanish Agency for Medicines and Medical Devices (AEMPS), the duty of which will be to advise the agency on issues relating to safety, enforceability and quality and which must coordinate with its counterpart at the European level. NEW POST-MARKET FOLLOW-UP MECHANISM: Safety has also been increased via the use of a new post-market follow-up mechanism, the purpose of which is to ensure that manufacturers document and operate a monitoring system after products have gone to market by means of a plan based on product type and risk. This will ensure that manufacturers regularly report the results and conclusions of their analysis over the useful life of the device. This plan must be used to collect information about events and their effects, relevant technical literature, complaints submitted by consumers, distributers and importers and information available in the public domain about similar medical devices. NEW CHECKS: Another amendment that could have a major impact on manufacturers is the inclusion of a scrutiny procedure (Article 44), which, for certain types of class III and class IIb devices, will enable the competent authorities to review the checks carried out by the Notified Body to verify technical documents. This constitutes a second check, which will involve a duplication of work. Competent authorities may also request further information, which could delay the procedure for a number of months and reduce any margin of advantage the manufacturer may have. Manufacturers of in vitro medical devices will experience a greater change as—under the current directive—one in five in vitro devices requires the involvement of the Notified Body whereas, according to industry data, the amendments implemented by the Regulations could mean that up to 80% of devices will require the involvement of the Notified Body. In short, the new Regulation on medical devices is much more demanding than its predecessor as it involves more mechanisms to ensure that the devices available on the market are safe and comply with the quality standards required to ensure that the health of patients and users of such devices is fully protected. Furthermore, the new features introduced in the Regulation require the industry to make major internal adjustments in order to be able to comply with the new requirements. These requirements will involve an increase in costs for manufacturers and oblige them to invest more time in getting a device to market. It will take time for manufacturers to implement these adjustments and for the industry to meet the demands such changes require. Therefore, in all Member States the new legislation will take effect three years after its approval for medical devices and five years after approval for in vitro devices. Certainly, the three-year period for medical devices could have been increased to five years, as with in vitro devices. However, the current period still provides the industry with a reasonable margin.
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