The medical device category includes a wide variety of products intended for human use, mainly for medical purposes: instruments, apparatus, devices, software, implants, reagents, materials, and others. The purposes of products in this category are equally diverse: diagnosis, prevention, and treatment of diseases; compensation for injuries or disabilities; modification of pathological processes or conditions; fertility control; disinfection and sterilisation of medical devices; and many others.
Despite such a wide variety of medical devices and equipment, the requirements applied in the regulatory process and the conformity assessment, notification, and registration procedures depend not only on their characteristics but also on the risks they pose, which determine the classification of devices into risk classes as defined in EU regulations. The device class determines the further steps and requirements to be implemented in order to supply the product to the target markets. In this process, it is necessary to consider the requirements of state institutions, the EU and national legislation, as even minor non-compliance can cause long-term damage and financial losses.
Every year, we work with clients from more than 20 countries, while actively monitoring regulatory changes and analysing market trends. Working in this dynamic market, our experts are interested not only in applying best market practices, but also in identifying potential problems and proactively addressing them to ensure a smooth and high-quality regulatory process and that your product ends up on the right shelf.
Considering individual needs, we advise on various issues and participate in different stages of medical device regulation. Depending on your needs and preferences, consultations can take place in person, by phone, or online (in writing or by video call). We also have a network of reliable partners, thanks to which we can successfully implement multilateral projects in target markets where the supply of medical devices is planned.
The most common questions and topics we consult on:
- Requirements for medical devices of various classes, as set out in Regulations (EU) 2017/745 and (EU) 2017/746, as well as transitional requirements.
- Obligations and responsibilities of medical device manufacturers, trademark owners, authorised representatives, importers, and distributors.
- Assessment of the medical device class.
- Information on the requirements, procedures, and state fees applicable to medical devices in the target market.
- Conformity audit of medical device labelling.
- Marking of medical devices with the CE symbol and UDI mark.
- Audit of the conformity of information on medical devices provided on websites.
- Representation of medical device manufacturers, importers, and distributors before competent authorities.
- Medical device vigilance and reporting of serious incidents.
- Notifications of unsafe products under Regulation (EU) 2023/988 on general product safety.
- Review of documents for medical devices imported from other EU countries and assessment of their compliance.
- Regulatory translation of medical device documentation, labels and IFU.
- Borderline products.
- Products classified as medical devices that do not have a specific medical purpose.
- Introductory consultations for market newcomers.
- Coordination and implementation of multilateral projects.
These are just a few examples. We are ready to advise you on a wide range of issues and help you find the best solution for you.
Countries where we provide this service
Although the basic regulatory requirements for medical devices are set out in EU legislation, the notification, registration, and advertising of medical devices are closely linked to national requirements. We advise on a wide range of issues, help you find the best solution, and ensure legal compliance of products in the Baltic countries and other EU countries (subject to a separate agreement).
