The European Commission (EU) has decided that the current European Device Directive, or MDD, on medical devices is not strict enough. It has been rewritten in accordance with the rules defined by the European Union Regulation for Medical Devices, or MDR. This paper aims to investigate the peculiarities of and differences between the mentioned documents, as well as to provide recommendations on how a company may be MDR complaint.
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EU countries created a European common market in an effort to ensure the free movement of goods, services, capital, and labor. At the time of adoption of the MD Directive, there was a large number of barriers to free trade in European countries. Thus, due to the launch of the process of creating a common market in the early 1990s, a Directive was adopted to rid this market of these barriers and simplify the movement of medical goods.
The Directive regulates affairs related to medical devices; the latter implies equipment, material, apparatus, software, or any other item used for therapeutic purposes, as well as for the following. The first is for the diagnosis, prevention, and treatment of diseases, injuries, and disabilities. The second is for studying or changing of a physiological process or anatomy; the third is for contraception. The Directive applies to medical devices if the above objectives cannot be achieved using chemical, pharmacological, and metabolic means (“Medical Devices Directive”). This divides medical devices into four classes (class I, IIa, IIb, and III) depending on many parameters, for example, purpose or complexity of use.
The fundamental requirements of the Directive can be formulated as follows. Medical equipment must be safe for patients and users when properly installed and operated. The safety of equipment should be ensured directly by the state. The devices must strictly comply with protection and health laws. Then, goods that have been successfully tested by the competent authorities receive the CE mark and have the right to enter the EU markets freely.
Medical devices are classified according to their application; two consultative committees are set up to advise the European Commission on the implementation of the requirements of the Directive. The first deals with issues regarding standards and technical regulations, and the second – with the equipment. In the case the devices pose a threat to human life and health, the state is obliged to withdraw it from circulation and notify the European Commission and EU countries about it.
MDR is a new regulation on the certification of medical devices and equipment within the European Union. It entered into force on May 26, 2017, and is necessary for organizations whose medical devices are exported to EU countries. The primary aim of the Regulation is to unify the rules regarding medical products in all EU member states. The other ones are the protection of the safety and health of EU citizens, free and fair trade in medical devices, and unification of the legislation according to the world standards in the medical sphere.
It seems reasonable to state that innovations in comparison with the MDD are not global but very laborious as they require the introduction of the following. First, it is post-marketing surveillance – authorized bodies will play a more important role in the supervision of the manufacturer’s operations (Wyler). Then, unique device identification (UDI) is to facilitate tracking throughout the supply chain. There are also several added requirements for importers and distributors – economic operators (Regdesk).
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A responsible employee should ensure compliance with the regulatory requirements of the enterprise and report this to authorized bodies. Finally, the rules for medical equipment for non-medical supplies similar to medical devices, usually intended for cosmetic purposes, are to be implemented.
Nevertheless, manufacturers still face issues, including re-categorizing their devices, correcting technical files and clinical assessment reports, and implementing the necessary MDR changes in their management operations. From a legal perspective, critical difficulties with the implementation of the MDR occur.
In addition, given the COVID-19 pandemic, these difficulties can now be even tougher to solve. For instance, the European medical device database, Eudamed, is still not functioning, and its creation was delayed. Meanwhile, the inclusion of medical device codes in this database is one of the key requirements of the new Regulation.
In light of the impact of the COVID-19 pandemic on the market, the European Commission claimed that it aims to delay the MDR from May 2020 to May 2021. It has published a proposal to suspend its application until May 26, 2021 (The European Commission). The authorities had to make a decision quickly enough – the previous deadline for the entry into force of the Regulation was May 26, 2020.
Delaying the MDR relieves pressure on national authorities, producers, and other industry actors. It provides them with the opportunity to concentrate on urgent targets related to the struggle against COVID-19. It is also an essential action that helps patients and healthcare establishments during the pandemic (Crotti). Medical devices can be delivered to the EU market for another year in accordance with the provisions of the applicable EU Directive 93/42 / EEC MDD and local law of the country of delivery.
An extra year is a possibility for the medical equipment market and regulatory authorities to become confident that they are MDR complaint despite the COVID-19. Indeed, even before the pandemic, the readiness of the sector for the introduction of the new Directive was a big issue. According to a number of surveys, less than a third of manufacturers expected and aspired to be ready for the MDR in May 2020. Most planned to meet its provisions using transition periods – by May 2024.
The prerequisites for the creation of new regulatory documents appeared after some incidents that arose during the application of the Directive, for example, with the fraudulent production of silicone PIP implants and metal hips. These cases revealed the shortcomings of the existing legal system and reduced the trust of patients, consumers, and medical workers in the safety of medical devices. Currently, the European medical device control system has a well-planned strategy that takes into account local and individual national requirements.
The difference between the MDD and the MDR is that all EU Member States are legally obliged to comply with the Regulation without any changes. This implies that the EU can take measures to punish countries, manufacturers, importers, distributors, or even private individuals. It may happen if the EU discovers or suspects that any violations have been committed, and local authorities are not making enough efforts to ensure compliance with the Regulation.
Another crucial difference is that “the scope of the MDD did not encompass medical purpose devices and AIMD, these are both included under MDR” (the FDA Group). Moreover, according to the FDA Group, “Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and postmarket expectations.” The mentioned differences allow assuming that despite there is a number of critical changes, the essence of EU medical device policy will not be fluctuated substantially.
There might be four crucial points to ensure a company is MDR complaint. First, it is essential to determine the scope and classification of a medical device. It will affect the subsequent actions; therefore, it is vital to take them carefully and accurately, especially if the product may have a border medical purpose. Second, to ensure that the necessary processes and resources are carried out using a quality management system and appropriate documentation (Dragan).
Third, clinical evaluation should begin with the development of a proper plan. Further actions depend on the classification and novelty of the device, but the post-market clinical follow-up (PMCF) is required (Emergo). Finally, in order to minimize risks, a firm is to verify its compliance with crucial safety and performance provisions.
It should be emphasized that before entering the market, a firm is to evaluate its compliance with the MDR accordingly. A gap assessment might be considered as a tool for making proper decisions that help to determine four critical factors. These factors are “types of new test data necessary for MDR compliance, the scope of new data, required labeling changes, new files, and agreements needed for compliance” (Fontanazza). It might be rational if companies will cooperate with experts from technical, regulatory, and clinical groups so that they could provide firms with reliable reports.
In conclusion, it seems reasonable to claim that the MDR is a significant regulation that might make the market of medical devices more transparent and sustainable. The investigation revealed that its provisions do not bring substantial changes to the policy. Nevertheless, a company that aspires to enter this market is to conduct a sufficient gap assessment to figure out whether it is compliant to the MDR.
Crotti, Nancy. “BREAKING: EU MDR is postponed by 1 year due to coronavirus pandemic.” Medical Design & Outsourcing. 2020. Web.
Dragan. “Transitioning from MDD to MDR – What You Need to Know.” Climedo. 2020. Web.
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Emergo. “Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation.”. 2019. Web.
Fontanazza, Maria. “First Step in EU MDR Compliance: The Gap Analysis.” MedTech Intelligence. 2018. Web.
“Medical Devices Directive – 93/42/EEC MDD.” DnvGl. Web.
Regdesk. “6 Major Differences Between EU’s MDR/IVDR and MDD/IVDD.”. 2020. Web.
The European Commission. “Medical Devices.”. Web.
The FDA Group. “MDR vs. MDD: 13 Key Changes.”. 2018. Web.
Wyler, Jessica. “The Intended Purpose – or, What Does Your Medical Device Do?” Decomplix. 2020. Web.