Import and Distribution

The import and distribution of medical devices are subject to the new regulations (EU) 2017/745, known as the Medical Devices Regulation (MDR), and (EU) 2017/746, known as the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations establish and expand the requirements for importers and distributors in the industry. These regulations aim to ensure devices can be traced and enhance safety control and monitoring.

The information provided is intended to offer guidance and insights into the import and distribution of medical devices within the EU legal system and description of detailed requirements on the country level based on the Polish legal system. The Polish Medical Devices Act of April 7, 2022 provides detailed guidelines and regulations that supplement the above-mentioned regulations.

Registration of Importers and Distributors

Before marketing a medical device for the first time, importers are required to obtain a unique Single Registration Number (SRN) by applying to the Competent Authority. (In Poland: President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products). The President of The Office also maintains a list of medical device distributors.

Discover the essential steps before marketing your medical device

Obligations of Importers and Distributors of Medical Devices

The requirements for importers of medical devices are outlined in Article 13 of the MDR and IVDR regulations. Similarly, the requirements for medical device distributors are specified in Article 14 of both regulations.

See what the obligations are for importers and distributors of medical devices

Implementing Quality Management Systems at Importers and Distributors

Importers and distributors often opt to implement a quality management system to fulfill their responsibilities effectively. The widely preferred system is ISO 13485. An efficient quality system ensures that medical devices comply with regulatory requirements. It also ensures accurate identification and control of non-conforming, defective, or inadequate medical devices. Furthermore, it ensures that the importers' or distributors' activities align with the regulations.

Learn how we can assist you in implementing a quality management system

Advertising and Marketing of Medical Devices

The rules governing the advertising of medical devices, systems, and treatment kits are described in general in the EU MDR and IVDR regulations. Rules are different in various European Countries e.g., Polish Medical Devices Act of April 7, 2022, the Polish Regulation of the Minister of Health on Advertising of Medical Devices of April 21, 2023. These regulations specify the necessary requirements and prohibited elements.

Learn what is allowed and what is prohibited in medical device advertisements

Non-compliant products

If a device is suspected or found to be non-compliant with the MDR or IVDR, importers or distributors must suspend its marketing until compliance is assured. The same applies when the device may be adulterated or poses a serious risk to the user. Importers or distributors with concerns regarding the device's compliance or safety should promptly notify other stakeholders in the supply chain, as well as relevant authorities.

See what obligations an importer and distributor has with regard to non-compliant products

Prohibitions and Penalties in Medical Device Regulations

European Countries can add additional prohibitions and penalties. Article 16 of the Polish Medical Devices Act of April 7, 2022 specifies a list of forbidden actions that apply to importers and distributors, with severe penalties for violations. The act also outlines the consequences of failing to comply with the requirements of the MDR and IVDR regulations.

Learn about the actions importers and distributors of medical devices must avoid and the applicable penalties for non-compliance

How can we help you?

Our team is available to assist you in managing complaints and gathering feedback from the market.
We can participate in evaluating information intended for users, such as user instructions, labels, and packaging.
We can provide assistance with the product notification or registration processes.
We are prepared to help your company achieve compliance with the MDR Medical Device Regulation.
We are prepared to help your company achieve compliance with the IVDR In Vitro Diagnostic Medical Device Regulation.
We will take care of the necessary paperwork for product notification.
We offer consulting services for OBL/OEM (Own Brand Labeling / Original Equipment Manufacturer) collaborations.
Trust us to implement an effective quality system and conduct audits for you.
We can provide support in marketing and distributing your products in the EU market.