How the medical device regulation system enhances patient safety
Medical device manufacturers must ensure the conformity of their products with the applicable legal requirements. But who enforces the regulations and what are the consequences of non-compliance?
Non-compliant medical devices primarily harm patients; in order to improve patient safety, stricter requirements will be enforced from May 2020 with the Medical Devices Regulation (MDR), which will create more binding obligations for all parties involved.
Medical devices are a vital part of modern healthcare
Medical devices are indispensable in all areas of the healthcare system; they play an important role, for example, in diagnosis, prevention, and treatment of diseases and injuries. The question of whether a product qualifies as a medical device is not always easy to answer. It ranges from sticking plaster, sophisticated pacemakers, or scalpels to software, for example a smartphone app. The latter can also qualify as a medical device (so-called Software as Medical Device SaMD) depending on its function and intended use. Especially health and fitness apps are often located in a grey area (read more about the definition and qualification of a medical device here).
Whether or not a device or a software qualifies as medical device often depends on details: individual functions or even the wording of the intended purpose can be decisive here. The consequences should not be underestimated: the development of a medical device in accordance with the requirements of the applicable regulation is laborious. With the entry into force of the Medical Device Regulation (MDR) 2017/745 (EU) in May 2020, the risk classification of certain product types, in particular SaMD, will also be tightened and a lot of SaMD will be up-classified.
Medical innovations play an important role for high-quality healthcare as people rely on these devices to be safe and incorporate the latest progress in science and innovation. Computer technology and the Internet have found their way into medical technology, changing products and production processes and helping to improve patients’ quality of life and the efficiency of care. New technologies (such as nanotechnology or 3D printing) can present many opportunities, but also new risks and dangers. Manufacturers of medical devices operate within a strictly regulated framework and with the implementation of the Medical Devices Regulation in May 2020, attempts are being made, among other things, to do justice to the innovations and to update the rules to reflect substantial technological and scientific progress. Switzerland is adapting its medical devices legislation to the new EU legislation in order to secure market access for Swiss manufacturers.
The regulatory framework imposes requirements on manufacturers, before and after market entry
The regulatory framework of the EU stipulates that medical devices have to undergo a conformity assessment and manufacturers are obliged to clearly and visibly mark compliant products with a CE mark. The higher the risk potential of the device, the more proof with regards to safety and performance must be provided by the manufacturer before and after market entry. Depending on the risk associated with the product, notification requirements may apply and conformity assessment procedures are allocated.
For classical medical devices in Class I (non-sterile and without a measuring function), the conformity assessment can be carried out by the manufacturer. With the declaration of conformity, the manufacturer confirms that the product meets all the essential requirements of Annex I of the Medical Devices Directive 93/42/EEC or, as of May 2020, the essential safety and performance requirements of Annex I of the MDR. However, Class I medical devices may be subject to a notification duty when they are first placed on the market. The notification must be made to the national competent authority.
Products with a higher risk classification, on the other hand, must undergo a conformity assessment procedure and periodic controls carried out by a conformity assessment body. Compliance with the essential requirements is, in this case, verified by a private notified body, which has been designated by an EU country to the European Commission. The national designating authorities conduct inspections for designation and renewal of designation and supervise the notified bodies according to defined procedures.
The regulatory system defines tasks of authorities, notified bodies, and professional users
The CE marking itself therefore does not involve an official authorisation procedure. Despite inspection by the notified body, the responsibility for conformity with the legal requirements remains with the manufacturer. However, the regulation of medical devices ensures that notified bodies and authorities fulfill their specific tasks. In Switzerland, the Therapeutic Products Act (TPA) and the Medical Devices Ordinance (MedDO) also regulate the duties of professional users of medical devices.
The manufacturer has the obligation to monitor the medical device after entry to market and to report problems and incidents (Postmarket Surveillance (PMS)) as well as to collect and evaluate data on their medical devices during their use. This enables manufacturers to carry out safety measures, corrective actions, and recalls (vigilance). In this respect, too, the regulatory framework lays down precise requirements to ensure patient safety throughout the entire lifetime of a medical device. However, it is not only the manufacturer who is obliged to report incidents; hospitals and doctors are also obliged to do so, and incidents are also increasingly being reported by patients. The new Medical Device Regulation (MDR) enhances the obligations to participate in product surveillance to all economic participants in the supply chain, such as manufacturers, authorised representatives, importers, and distributors (you can read more about the obligations of distributors here).
The national competent authorities have a monitoring role within the framework of market surveillance with a focus on effective market surveillance. This includes monitoring conformity of assessment bodies, inspections of manufacturers and hospitals, and control over medical devices placed on the market. The national competent authorities investigate reports of non-compliant products and serious incidents and supervise clinical trials with medical devices that are not yet marketable. In the event of non-compliance, the authority can enforce necessary corrective actions.
Defective medical devices hit the headlines
Side effects caused by medical devices are unavoidable, but a functioning regulatory system requires that avoidable damage is prevented. If patients suffer damage, the entire system is often called into question, as extreme examples such as the PIP scandal, implant files, and the use of rusty and faulty cannulae in Swiss hospitals make the headlines.
The question of the responsibility of a notified body was raised in the case concerning the health-endangering breast implants of the French manufacturer Poly Implant Prothèse (PIP) and was at least partially answered by the European Court of Justice (CJEU). A German patient has asked the notified body of the manufacturer for compensation for non-material damage. In her view, the notified body should have uncovered the fraudulent activities during the manufacturer’s inspection. The case was taken to the CJEU, which ruled that the Directive did not impose a general obligation on the notified body to proactively search for evidence (product testing and unannounced audits and/or review business records). According to the CJEU, a notified body can only be held responsible if it has indications of defective products or a malfunction on the part of the manufacturer and ignores them. The case concerning breast implants has been on the courts’ agenda for years, and the CJEU ruling stipulates that notified bodies may be liable to patients if they violate their obligations.
At the end of 2018, the research under the title Implant Files was published by the International Consortium of Investigative Journalists, which uncovered serious safety deficits in implants and other medical devices. In this scandal, again, the notified bodies were the focus of criticism, as was the system of certification by private institutes. In addition, the market surveillance did not work in many of these cases because hospitals did not report complications.
The fact that market surveillance only works if all fulfil their reporting obligations is also demonstrated by the case of rusty and faulty needles in Swiss hospitals, which was made public in January 2018. Swissmedic opened criminal proceedings against hospitals that had not reported the incidents and fined the hospitals concerned.
There are repeated demands that more state controls should be carried out and that patient safety cannot be guaranteed by the existing system. It is understandable that extreme examples, which become known through headlines, lead to uncertainty and shatter confidence in the surveillance system, the products, and the reliability of the manufacturers.
The new Medical Devices Regulation can partly be seen as an answer from the EU legislators to such scandals. In response to the PIP scandal, the EU initiated immediate measures and called on the national competent authorities to tighten controls on notified bodies and to strengthen market surveillance by random controls.
What are the consequences of placing non-compliant medical devices on the Swiss market?
Within the framework of market surveillance, Swissmedic ensures that the medical devices in the Swiss market satisfy all the applicable legal requirements. These state control tasks are carried out by receiving and acting on reports made on the basis of suspicion as well as doing follow-up checks in the form of random tests or inspections.
The executive bodies, mainly Swissmedic but also the Cantonal and customs authorities, are authorised to take administrative measures against non-compliant medical devices and their manufacturers. These measures range from complaints and sales bans to the closure of companies.
The placing on the market of medical devices which do not comply with the legal requirements of the Swiss Medical Device Ordinance constitutes a criminal offence which can be punished by imprisonment or a fine of up to CHF 200,000.
In addition, according to the Swiss Code of Obligations and product liability, damage caused by a product can also have liability consequences. If this damage is caused by a medical device that has not been certified and manufactured in accordance with the legal specifications, it is also difficult for the manufacturer to prove that a product defect is not responsible for the damage.
Placing a medical device on the market that does not meet the legal requirements (is faulty or incorrectly labelled) can therefore have serious consequences for the manufacturer. However, service providers such as hospitals or doctors are also responsible for checking that the medical devices used by them have been certified accordingly. If they fail to do so, they are violating their duty of care and are liable to prosecution.
As far as SaMD is concerned, the Federal Council has made a specific statement on the consequences for non-compliant placing on the market following a ruling by the European Court of Justice (CJEU). It has clearly stated that software can also be a medical device and must bear the CE mark and that false declaration is not a trivial offence.
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