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The new regulation for medical devices came into force on May 26, 2022Its purpose is to introduce the necessary instruments for the application in the territory of the Republic of Poland of Regulation (EU) 2017/745, of the European Parliament and of the Council of April 5, 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic medical devices. The law seeks to comprehensively regulate and streamline the market for medical devices, as well as in vitro diagnostic medical devices, taking into account small and medium-sized enterprises.
Does the new legislation introduce many significant changes? Will the reforms affect all players in the medical device industry? How should Polish companies approach the new requirements? How do we develop the right strategy to adapt to the changes? In this article, we will try to clarify the most important issues of the upcoming changes.
Which significant changes do the new regulations introduce?
The EU legislature's new regulations provide opportunities to raise product quality and safety standards by taking into account medical device guidelines developed at the international level. Of particular relevance in this regard are regulations on unique identification codes for medical devices (UDI), technical documentation, classification rules, conformity assessment procedures and clinical trials, as well as general requirements in the field of safety and performance.
Among the new solutions introduced by the EU, special attention should be paid to the definition of new rules for the classification of medical devices (Annex VIII, Classification Rules). Until recently, there were 18 rules in the classification, we now have 22. This will make it possible to define device classes more precisely. However, as a result of the changes to the classification rules, some devices have been assigned to higher classes, which forces manufacturers to meet higher quality requirements. The Polish Law of April 7, 2022, on Medical Devices, as part of the implementation of the provisions of the European Parliament's regulations, specifies the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products as the competent authority to implement the aforementioned regulations and the authority responsible for notified bodies to perform conformity assessment activities. New stricter rules for carrying out conformity assessments (prior to placing a product on the market) for products in higher classes additionally require the participation of a notified body in the process, and for the purpose of conducting such assessments for Class I devices, the manufacturer itself is authorized.
The exceptions within Class I are sterile devices, devices with a measuring function, and a completely newly distinguished group of devices - reusable surgical instruments. Although they belong to Class I devices, the participation of a notified body is necessary for their conformity assessment procedure, and the scope of its participation has been precisely specified. The general position of notified bodies in relationship to manufacturers has also been strengthened; they have the right to perform unannounced audits and to subject products to physical or laboratory tests.
The UDI (a new system of unique identification codes) and Eudamed (a European database of medical devices) are to be responsible for the higher traceability of medical devices, and consequently for better efficiency of measures regarding the safety of devices already on the market. The purpose of the electronic database is primarily to make data available, and to increase its quantity and quality.
Among other things, information on devices, their certificates, clinical trials or economic operators in the EU market is and will be collected and made available in it. In summary, Eudamed is intended to serve as a tool for the exchange of information between manufacturers and competent authorities.
The EU legislature is also changing the existing regulatory approach to post-market surveillance after a product is placed on the market, made available on the market and put into use. Competent authorities must ensure the review of documentation and physical and/or laboratory tests, and draw up an annual plan of market surveillance activities, which should primarily include checks on the conformity of product properties and performance.
How does the new Polish Medical Devices Law differ from the EU Regulation (MDR)?
The current Law on Medical Devices, which went into effect on May 26, 2022, specifies:
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Obligations of business entities, public health institutions, medical entities, medical professionals, and other entities;
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Jurisdiction, authority, and competence of the bodies;
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Administrative penalties;
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Rules and procedures for conducting a clinical trial of a medical device and performance testing of an in vitro diagnostic medical device;
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Amount and mode of payment of fees;
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Rules for use and maintenance of devices;
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Rules and procedures for conducting clinical trial inspections;
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Rules for conducting and supervising advertising of devices.
In addition to clarifying new issues arising from the Ordinance, it is intended to facilitate the application of the EU Ordinance under Polish law, regulating in particular the advertising of products and supervision thereof, as well as administrative penalties, and the powers of the authorities and entities concerned.
The Act of April 7, 2022, unlike the earlier Act of May 20, 2010 on medical devices, explicitly regulates according to the principles on how medical devices can be advertised and how supervision of their advertising is to be carried out. What's more, these provisions also apply to treatment systems and kits. The provisions in question dictate that advertising of a device to the public should present information in a clear and lucid manner for the average user of the device.
At issue are the medical and scientific phrases used, as well as the citation in advertising of scientific studies, opinions, literature or scientific papers and other materials aimed at people other than average users. In addition, the use of images of medical professionals or those claiming to be such is prohibited which means that advertising will not be allowed to feature persons representing medical professions or even suggesting the practice of such professions. Mandatory messages and the form of the advertisement are also specified in detail - it must not in any way induce children, parents or other adults to purchase the advertised products. The content and form are to be purely informational. The above rules apply to both advertisements broadcast in the mass media and leaflets, presentations, conferences, trade fairs, etc. However, they do not apply to information placed on packages (and attached to packages), trade catalogs, price lists, or technical specifications of the device. Supervision of the advertising of a system or treatment kit is exercised by the President of the Office (i.e., the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), and the advertising of medical devices by the competent Minister of Health with respect to entities performing medical activities, and by the Chief Sanitary Inspector with respect to the rest.
The Polish law, as part of the implementation of the European Parliament's regulations, designates the President of the Office as the competent authority to implement the new regulations and the authority responsible for notified bodies - their designation, possible suspension or partial or complete cancellation. Potential disputes that may arise between the manufacturer and the notified body regarding the classification of medical devices must be resolved by the President of the Office through an administrative decision. The notified body, in turn, is obliged to submit an assessment plan for quality management systems at the manufacturer's site, if requested by the President of the Office. It should be remembered that documents related to the application of a conformity assessment body for designation and with the evaluation of this application, as well as certificates of conformity issued by notified bodies, must always be prepared in both Polish and English. For sterile devices, devices with a measuring function and reusable surgical instruments, although they belong to Class I devices, the participation of a notified body is necessary in their conformity assessment procedure, which also has the right to perform unannounced audits and to subject products to physical or laboratory tests.
Who will be affected by the changes?
The new responsibilities of manufacturers, therefore, include generating the code and placing the relevant code elements on the carrier in the declaration of conformity and on the label or packaging of the product. The tasks also include registering with the Eudamed database to obtain a unique registration number. Manufacturers have become entities fully responsible for ensuring that their marketed products are designed and manufactured in accordance with the requirements of the Regulation. From now on, every manufacturer must have a person responsible for regulatory compliance (PRRC - Person Responsible for Regulatory Compliance) in their company and must have proper financial provision for possible liability. This person's responsibilities include establishing and preparing documentation, implementing and maintaining a risk management system, as well as conducting clinical assessments and compiling and updating the technical documentation of its products. He or she must be a person who has completed the relevant studies and has the required expertise in the field of medical devices, and his or her qualifications are confirmed by a relevant diploma and/or certificate. The EU legislator has also added planning, establishing, documenting, implementing and updating a post-market surveillance system on the market for each device as the manufacturer's responsibilities, according to the risk class and as appropriate for the type of device.
The new legislation introduces changes that will affect not only manufacturers, but also other market participants - importers and distributors. They must confirm that the product is accompanied by all the necessary information for the placement of which its manufacturer was responsible, as well as whether it has assigned a UDI code. Moreover, both entities are obliged to verify that the CE marking has been affixed to the product and that a declaration of conformity has been prepared. The importer, as well as the distributor, must ensure that the medical devices are stored or transported in appropriate conditions so that they comply with the conditions set by the manufacturer. In addition, both groups of entities have been obliged to manage a register of complaints of non-compliant devices or cases of withdrawal from use or from the market. The manufacturer and the authorized representative must be informed of all information and comments made by healthcare professionals or patients. All complaints should also be forwarded to the importer of that device.
What should Polish companies do to smoothly start complying with the new regulations in force?
The complexity of research and development work and the dynamics of changing laws and regulations placing increasing emphasis on quality, safety and health issues have made it impossible for the pharmaceutical and medical device industry to function without outsourcing. Companies operating in Poland wishing to adapt efficiently to the changes resulting from the Ordinance and the new Act should consider outsourcing at least some of their tasks. In addition to lower costs, the advantage of outsourcing is the relatively short implementation process and the fact that outsourcing and consulting companies offering such services know their job very well.
During the current period of change, this form of cooperation can serve to carry out such work as:
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Evaluation of the compliance of the product/system/treatment set with regulatory requirements;
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Preparation, implementation and maintenance of up-to-date technical documentation of the product/system/treatment set;
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Preparation of annual market surveillance action plans;
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Advising on new advertising campaigns;
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Support in maintaining risk management systems;
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Support in duties related to UDI system and Eudamed database;
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Training of employees on applicable new laws and regulations.
In the current situation, therefore, it is worth considering whether the use of external resources is the most cost-effective and convenient solution. In addition, the set direction of changes and approaches, both of the EU and Polish legislators, should be regarded as correct and giving our country hope for further actions aimed at ensuring the maximum possible level of safety of medical devices.
