Medical devices in the European Union are subject to the requirements of Regulation (EU) 2017/745 on medical devices (MDR). A product may only be placed on the EU market if it has successfully passed the CE conformity assessment procedure and is CE marked accordingly.
Responsibility for CE marking generally lies with the manufacturer. If the manufacturer is not based in the EU, they may appoint an EU Authorized Representative (EC-REP). If they do not, the importer is deemed to be the manufacturer and therefore bears full responsibility for CE conformity.
Medical devices - yes, or no?
Before market placement, it must be assessed whether the product qualifies as a medical device under the MDR. The correct risk class must also be determined (I, IIa, IIb, III, Is, Im, Ir), as this defines the specific requirements for the conformity assessment.
Borderline questions frequently arise – particularly with products at the interface with cosmetics, lifestyle, or wellness sectors. Colored contact lenses, ready-to-wear reading glasses, or products with temporary transitional provisions often lead to legal uncertainty.
We support you in clearly classifying and defining your product.
Conformity Assessment & Notified Body
The conformity assessment procedure depends on the risk class. Class I products do not require the involvement of a Notified Body—however, for all higher risk classes (IIa, IIb, III, as well as Is, Im, Ir), a Notified Body must be involved. The manufacturer selects the Notified Body, provided it is designated for the relevant product type.
Regardless of the risk class, the manufacturer remains responsible for key tasks, including:
- Establishing and maintaining a quality management system (QMS)
- Implementing a risk management system
- Preparing the technical documentation
- Conducting a clinical evaluation
- Assigning a UDI (Unique Device Identification)
- Setting up a vigilance system
- Appointing a Person Responsible for Regulatory Compliance (PRRC) as per Article 15 MDR
- Drafting the EU Declaration of Conformity
- Registering the product in EUDAMED
- Performing post-market surveillance and documentation
After successful assessment, the CE mark is affixed, and all legally required safety information is provided.
MDR Compliance from a Single Source
We support manufacturers, importers, and authorized representatives throughout the entire MDR compliance process – or in specific areas, as needed.
Our services include:
- Reviewing and evaluating existing documentation and test reports
- Commissioning additional testing at accredited laboratories
- Conducting safety assessments
- Preparing technical documentation
- Drafting CE marking elements
- Creating the MDR-compliant Declaration of Conformity
Whether for a single step or the complete process – we guide you reliably toward CE marking under the MDR.