Certification of medical devices
19 Jan, 2023
The placing on the market and use of medical devices in the European Union is regulated by law. The certification of medical devices raises many questions. What does this process look like and who carries it out? Let’s explain.
What is a medical device?
Details of legal regulations concerning medical devices in Poland can be found in the Act of 7 April 2022 on medical devices adopted by the Sejm. It is an extension of the EU requirements under the Regulations of the European Parliament and of the Council, the so-called MDR and IVDR.
According to the definition in MDR, a medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for at least one of the following specific medical purposes. These uses include, for example, prophylaxis, diagnosis, monitoring, prediction, treatment, prognosis, alleviation of disease, injury, disability, physiological or pathological condition. The definition emphasizes that a medical device cannot be used for treatment using pharmacological methods.
Simply put, medical devices are all medical tools, scales, ultrasound machines, thermometers, lasers, surgical masks, protective clothing, implants, specialized software for ultrasound, tomography, sugar measuring strips, condoms, cannulas, etc.. On the other hand, according to IVDR, a medical device is in vitro diagnostic equipment.
The manufacturer classifies all these things into a specific class based on the 22 rules of Annex VIII to the MDR regulation. According to Article 51 of this document, medical devices are divided into classes I, IIa, IIb, and III, taking into account their intended purpose and related hazards, duration of use, degree of invasiveness, or possibility of reuse.
Certification of medical devices – who carries it out?
The MDR Regulation defines most broadly what medical devices are and what requirements they must meet. Therefore, the certification of medical devices should be entrusted to a company that is a notified body in Poland in terms of carrying out the entire process in accordance with the framework of the EU regulation. Two units are at the forefront of this work:
- Polish Center for Testing and Certification S.A.,
- TÜV NORD Polska.
These are companies with extensive experience in the market, which conduct reliable and thorough research in the process of medical device certification.
What does the medical device certification process look like?
The medical device certification process focuses on tasks performed in sequence:
- Submission of the application.
- Review of the application by the notified body.
- Preparation of a certification offer.
- Preparation of documentation for assessment.
After a positive formal assessment, a substantive assessment of the documents takes place. Acceptance means the start of a quality audit. The last stage is the final review of the documentation and the decision on certification.
Regardless of the type of medical device, the certification procedure is divided into several stages. Rejection of the application at the stage of documentation acceptance is associated with its correction, removal of non-compliance, and re-consideration. Failure to take advantage of this opportunity means that the certificate will be refused. Qualified employees and auditors supervise the work at both TÜV NORD Polska and PCBC S.A.. The application for certification should be submitted on a form template provided by the selected unit, along with a set of required documents.
Certification of medical devices is a process that is worth taking care of, primarily to gain the trust of customers. It is an independent assessment and confirmation by a third party that the offered product meets the legal requirements and the manufacturer’s declaration of conformity.
Want to know more? Are you interested in news about medical devices? On our blog, there is also a text on what the introduction of medical devices to the market looks like.