Materiovigilance

At TOLLEON, we have the expert personnel with the necessary knowledge to support our business initiatives for medical device distribution. We also assist reliable partners and manufacturers in expanding their European market presence through our company.

Medical devices are categorized based on their risk level:

Class I (low risk): e.g., bandages, orthopedic products, ultrasound gel, corrective eyeglasses, etc.
Class IIa (medium-low risk): e.g., syringes, lancets, blood pressure monitors, etc.
Class IIb (medium-high risk): e.g., contact lens solutions, condoms, etc.
Class III (high risk): e.g., heart valves, collagen implants, etc.
Custom-Made Medical Devices: Manufactured according to a written prescription for a specific patient (e.g., dental products, prosthetics, etc.).
Every manufacturer of medical devices and active implantable devices must submit a technical dossier to an EU Notified Body for compliance assessment against essential regulatory requirements, obtaining CE certification.
CE-marked medical devices have free circulation across the European Union.
All medical devices must be registered with the National Medicines Organization of the respective country.
If the manufacturer is based outside the EU, they or their authorized EU representative must register in the National Manufacturers’ Registry of the respective Regulatory Authority before the product enters the local market.

We provide:

The preparation and submission of technical dossiers to an EU Notified Body for obtaining CE certification.

Complete registration services for non-EU medical device manufacturers, including submission of full product documentation (labeling, instructions for use, etc.) for legal market entry.

Registration of all medical devices manufactured or distributed in the European market in the Medical Device Registration Database

From basic Class I products to high-risk Class III medical devices and custom-made solutions, each category must meet strict EU compliance standards. With CE certification and national registration, devices gain unrestricted access across the European Union. For non-EU manufacturers, partnering with an authorized EU representative ensures seamless market entry and full regulatory alignment.