In today’s rapidly evolving medical landscape, the certification of medical devices plays a crucial role in ensuring product quality and safety.
The relevant regulations on medical devices were introduced into Polish law by the Act of May 20, 2010, on Medical Devices, along with its implementing regulations.
The process of obtaining medical device certification is complex and involves several key stages:
- Conformity Assessment
Before placing a medical device on the market, the manufacturer must conduct a conformity assessment to ensure the product meets all essential requirements specified in the relevant regulations and standards. Depending on the device’s risk class, this process can be carried out independently by the manufacturer or with the participation of a notified body. For Class I (non-sterile and non-measuring) medical devices, the manufacturer performs the assessment independently, issues a declaration of conformity, and marks the product with the CE symbol. For higher-risk devices, a notified body must be involved to conduct an objective evaluation, ensuring the product complies with the applicable regulations. This assessment includes risk analysis, technical documentation review, and, in some cases, clinical trials and audits. - Preparation of Technical Documentation
The manufacturer or notified body must prepare detailed technical documentation covering the device’s design, production, and testing. This documentation, compliant with EU Regulation 2017/745 (MDR), includes a product description, risk analysis results, clinical study reports, user instructions, and the declaration of conformity. - Clinical Trials
Depending on the device’s class, clinical trials may be required to confirm the product’s effectiveness and safety. These trials must adhere to relevant standards, such as ISO 14155, and are particularly crucial for higher-risk devices. - Audits and Inspections
The notified body conducts audits and inspections to ensure production processes comply with quality management standards, such as ISO 13485. On-site inspections verify that manufacturing practices align with declared standards. - Obtaining the Certificate of Conformity
Upon successful conformity assessment, the notified body issues a certificate of conformity, confirming the device meets all essential requirements. This certificate is necessary for obtaining the CE mark and must be retained by the manufacturer for regulatory oversight. - CE Marking
After receiving the certificate, the manufacturer can affix the CE mark to the device, its packaging, and accompanying documentation, enabling legal market entry in Europe. If a notified body was involved, its four-digit identification number accompanies the CE mark. - Labeling and Instructions for Use
Medical devices sold in Poland must have labeling and instructions in Polish or use harmonized symbols or recognizable codes. Devices supplied to healthcare providers may have documentation in English upon written agreement. - Product Registration with URPL
Before a medical device can enter the Polish market, the manufacturer must register it with the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) within 14 days of its first introduction. This registration involves submitting technical documentation, the certificate of conformity, and other required information.
A well-structured certification process ensures that medical devices are safe and effective, earning greater trust among healthcare professionals and patients alike. Legally, certification is a requirement for bringing medical products to market, ensuring compliance with European standards and enhancing overall patient safety.