What are medical devices?
By definition, a medical device is: “a tool, apparatus, device, software, implant, reagent, material or other
article intended by the manufacturer for use, either singly or in combination,
in humans for one or more of the following specific medical applications:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- to study, replace or modify an anatomical structure or a physiological or pathological process or condition;
- the provision of information through in vitro testing of samples taken from the human body, including those taken from organ, blood and tissue donors;
which does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on
the human body (but whose action may be assisted by such means)”[1].
Medical devices are therefore a broad group, covering products ranging from plasters and bandages to treatment support products, implants and specialist diagnostic equipment. Given the definition, many products can be considered to be medical devices, but their classification is decided by the manufacturer by assigning the appropriate purpose. This decision may be challenged by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Disputed classifications shall be based on experience with similar products available on the market.
Medical devices regulations
The marketing and making available of medical devices is regulated by both EU and Polish legislation. In May 2021, Regulation 2017/745, commonly referred to as MDR, entered into force, replacing the previously applicable Council Directive 93/42/EEC (MDD). The new Regulation is an important step towards increasing the safety of patients ― users of devices because:
- it introduces stricter conformity assessment and post-market surveillance procedures,
- it requires manufacturers to submit clinical safety data,
- it introduces a system of unique device identification codes,
- it provides for the establishment of a European database on medical devices.
The new guidelines aim to standardise the requirements for such a wide range of products as medical devices across the European Union.
In Poland, a draft act adapting Polish law to EU regulations on the functioning of the medical device market was adopted in October 2021. It sets out the tasks of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, along with the information obligations of businesses operating in the field of medical devices, and introduces a system of administrative penalties for non-compliance with the regulations in force.
Medical device labelling
The year 2021 has brought about many changes to the labelling of medical devices. In May, with the entry into force of the MDR, new labelling requirements for medical devices took effect across the EU. Whereas in July, an update to EN ISO 15223-1 was published on symbols and information to be provided on the labelling, marking and information supplied with medical devices. The revision of the standard was intended to clarify the definitions and descriptions of the previously used symbols and to add new symbols adapted to the requirements of the MDR.
Proper labelling of a medical device requires manufacturers to include the following information on the packaging/label:
- name of the device;
- identification of the “medical device” category;
- CE mark with the number of the notified body for the devices concerned;
- name and address of the manufacturer;
- information necessary to identify the device and the contents of the package;
- intended use of the device where this may not be obvious to the user;
- serial number of the device preceded by the word or symbolic term “SERIAL NUMBER”;
- UDI carrier;
- expiry date or production date of the device;
- information on any special storage or handling conditions;
- warnings or information on necessary precautions;
- qualitative composition of the device and quantitative information on the principal component or components responsible for achieving the principal intended action in the case of devices which are absorbed by the human body or dispersed locally in the human body.
Incorrect labelling of a medical device can have very serious consequences in terms of the safety of the device’s use or the imposition of a financial penalty in accordance with the rules laid down in individual Member States. In Poland, the maximum administrative fine for misrepresenting the intended use, safety and performance of a product is PLN 5 000 000.
Placing medical devices on the market
Before medical devices are placed on the market for the first time, they must undergo a conformity assessment procedure. It confirms whether a product meets all the general safety and performance requirements that apply to it. The procedure is carried out according to the class of the medical device which indicates the risk arising from its use. Following the conformity assessment, the manufacturer draws up a declaration of conformity and attests in it that the device complies with the general requirements applicable to it. These devices bear the CE mark.
An EU certificate of conformity is issued for devices in the assessment of which a notified body has participated, attesting that the device complies with the general requirements applicable to it. These devices bear the CE mark and, in addition, the number of the notified body.
In order to ensure patient safety, prior to the introduction of a medical device into the EU market for the first time, the manufacturer is obliged to notify the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – within 14 days.
Due to the transition period related to the change from MDD to MDR, products registered in two ways may be marketed during this period. Products for which the CE certificate of conformity with MDD 93/42/EEC was issued before 26 May 2021 can continue to be manufactured and placed on the market until the expiry of the certificate but not later than 27 May 2024. In turn, products of class I, which in accordance with the MDD did not require certification with the participation of the Notified Body, and in accordance with the MDR Regulation will be subject to certification, can continue to be manufactured and placed on the market also until 27 May 2024, provided that a declaration of conformity with MDD 93/42/EEC is issued and submitted to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products before 26 May 2021. However, during the transition period, manufacturers of such products must meet two conditions under the MDD:
- no significant changes may be made to the design or the intended use until 27 May 2024, otherwise MDR certification will be required;
- the manufacturer should introduce new requirements relating to post-market surveillance, market surveillance, observation, registration of economic entities and products.
Other products must fully comply with the regulatory requirements of Regulation MDR 2017/745 before being placed on the market.
Footnotes
[1]
https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:02017R0745-20200424&from=EN Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) Article 2, Item 1.
Author
Pion R&D, Curtis Health Caps