Before starting medical device supply to the EU, it is necessary to assess the product class. The device class determines actions that the manufacturer, authorised representative, importer, and/or distributor must take to confirm legal compliance and safety of a product before placing it on the market.
Under Regulation (EU) 2017/745, medical devices are classified into four classes: I, IIa, IIb, and III. A higher class means that the product poses a greater risk to the user, so devices that pose a risk are subject to appropriate requirements for safety, effectiveness, and conformity assessment, technical documentation, and clinical investigations.
The manufacturer itself assesses the conformity of Class I medical devices and prepares the declaration of conformity without the involvement of a notified body. Devices in this class must be registered in the country of manufacture, but do not need to be notified before being placed on the market in each EU country. A notified body must be involved in the conformity assessment of higher-class devices. So far, they must also be notified before being placed on the market in many EU countries.
Based on good market practices and successful customer consulting experience, INTRA VIRES experts:
- Help assess and define the appropriate classification of medical devices.
- Provide information on the requirements, procedures, and state fees applicable to medical devices in target markets.
- Represent you in registering your company and/or medical device in accordance with national requirements.
- Prepare and submit notification reports and accompanying documents to the competent authorities.
- Perform other necessary actions for the successful notification of medical devices in the Baltic countries and other EU countries.
Notification of medical devices: what should you pay attention to?
Before importing a medical device from third countries, it is necessary to assess whether the product can be supplied to EU countries, whether an authorised representative has been appointed, whether the product’s conformity has been assessed, and whether it bears the CE mark.
Transitional notification procedures and requirements may vary significantly between EU countries.
Countries where we provide this service
The notification and registration of medical devices are closely linked to national requirements. On behalf of our clients, we prepare and submit registration and notification documents to the responsible national authorities and help to ensure the legal compliance of products in the Baltic countries and other EU countries (subject to a separate agreement).
Why is it worth contacting experts?
Ensuring the legal compliance of medical devices requires not only regulatory knowledge but also in-depth practical experience working with different markets and products. Our experts will draw your attention to potential risks, help you prepare the documentation properly, and smoothly navigate all stages of registration and notification. We will also help you respond to questions from regulatory authorities.
We strive to build successful partnerships with responsible and quality-oriented clients to ensure a smooth, high-quality market entry for medical devices.
Contact us to discuss and find the most suitable solution for your needs!
