Medical Device Regulation 2017/745 (MDR)
Affixing the CE marking is legally required in order to place medical devices on the EU market. By affixing the CE marking, the manufacturer declares that the medical device complies with all relevant safety and performance requirements. In order to provide a product with a CE marking within the scope of the MDR, it must be classified as a medical device according to a risk class.
The MDR applies to medical devices, accessories of medical devices and medical software.
Medical devices are broadly defined within the MDR as any instrument, apparatus or appliance, software, implant, reagent, material or other item intended by the manufacturer to be used for humans for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of illness, injuries or disabilities.
Accessories of medical devices refer to articles that despite not being medical devices in their own right, are specifically intended by the manufacturer to be used with a medical device.
We refer to software as medical device software (‘MDSW’) when it meets the definition of software (i.e. a set of instructions that processes input data and creates export data) and at the same time is intended for a medical application as stated in the definition of medical devices. Medical software can be used independently (SaMD: Software as a Medical Device) or drives and/or influences the use of a medical device.
The MDR does not apply to:
- In vitro diagnostic devices (see Regulation 2017/746);
- Medicinal products;
- Cosmetic products;
- Human blood and its derivatives;
- Transplants, tissues or cells of human and animal origin;
- Food;
Our services for CE marking for the Medical Directive (MDR)
We provide consultancy services to manufacturers, importers, distributors and healthcare institutions in regard to the accurate and complete implementation of the Medical Devices Regulation (MDR). Our solutions and services are primarily focused on medical devices falling within risk class I and medical software/applications. You can rest assured that your product will be assessed professionally and impartially in order to place it legally approved on the market. In short we help you with:
- Qualification (is my product a medical device?) and classification (determination risk class) of medical devices
- Perform risk analyses in accordance with EN-ISO 14971
- Assessment of general safety and performance requirements
- CE marking of medical software and applications in accordance with EN 62304 and/or EN 82304
- Conduct product testing in accordance with EN 60601 standards
- Draw up (post-market) clinical evaluations
- Set up quality management system in accordance with EN-ISO 13485
- Establish post-market surveillance and vigilance system
- Verification of instructions, labels and markings (safety information) in accordance with EN 1041 and EN-ISO 15223-1
- Verification of Technical Documentation
- Advice on the registration of medical devices (UDI) and market participants in EUDAMED