The documents and other procedures required to supply medical devices to EU markets depend primarily on the class of the device. Class I devices do not need to be notified, but they must be registered in the country where the manufacturer or its authorised representative is located. The class also affects the labelling requirements.
Labelling refers to words, data, trademarks, and registered trade names associated with the medical device. The definition of labelling also includes pictograms or symbols indicated on the packaging, document, information leaflet, or sticker accompanying or referring to such a product.
All medical devices placed on the market must be labelled in the national language and comply with the requirements of European Union regulations. Compliance must be ensured both when introducing a new product to the market and when importing or exporting a product to new markets.
The labelling of medical devices is a complex service that helps to ensure compliance with the relevant standards for the product and to avoid risks such as product recall, harm to consumers, the need to re-label packaging, reputational damage, etc.
Considering regulatory standards and best practices in target markets, we advise on how to:
- Apply the relevant legislation.
- Formulate labelling instructions and claims.
- Avoid challenges arising in the labelling process.
If necessary, we assist clients at various stages of medical device labelling:
- Assess the legal compliance of packaging layouts with EU and national requirements.
- Prepare regulatory translations of label and package insert texts.
- Assess the compliance of labelling information (texts and/or layouts), provide comments and recommendations on mandatory and additional information.
- Assess the compliance of labelling with advertising requirements.
- Provide consulting services for the creation of packaging layouts and sticker layouts
- Design sticker layouts.
Countries where we provide this service
The labelling of medical devices is carried out in accordance with EU regulations, but some aspects are also related to national requirements. We provide regulatory translations of medical device labels, information leaflets, and technical documentation into national languages and ensure legal compliance of product labelling in the Baltic countries and other EU countries (under a separate agreement).
Placing medical devices on the market: what to pay attention to?
- Every medical device placed on the market must be labelled in the official language.
- Medical devices must be accompanied by instructions for use. This is not mandatory for Class I and IIa medical devices if the device can be used safely without such instructions.
- All medical devices, except those belonging to class I, must be notified.
- So far, product notification must be carried on in each country following local requirements.
- Medical devices also include certain products that do not have a specific medical purpose, such as products intended for use as facial or mucosal fillers in subcutaneous injections in aesthetic clinics.
Why is it worth consulting experts?
Correct labelling of medical devices ensures not only legal compliance, but also transparent communication with the consumer and helps to expand the product into new markets more smoothly. With the help of INTRA VIRES experts, you will be able to better understand the nuances of the labelling process and receive specific recommendations and valuable insights that will help you effectively address the challenges that arise throughout the process.
We strive to build successful partnerships with responsible, quality-oriented customers to ensure a smooth and secure market launch of medical devices.
Contact us and let’s find the best solution for you together!
