European Medical Device Regulation 2017/745

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 of the MDD/MDR, it must be classified as a medical device, classified 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.

Medical Devices – Our Expertise

Certification Company is an independent all-round regulatory specialist in the field of CE marking of medical devices. 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 pragmatic solutions and services are primarily (but certainly not exclusively!) focused on medical devices falling within risk class I and medical software/applications. Provided that entire CE conformity assessment procedures are assigned to Certification Company, we offer you our expertise on an ad hoc basis, subject to the the following conditions:

1. MDR base: telephone and email guidance by a specialist;
2. MDR-intensive: consultancy services provided by a specialist through direct communication (telephone and video teleconferencing);
3. MDR-on-site: on-site consultancy services.

How can we help you?

  • Carry out MDD-MDR Gap Analysis;
  • Qualification (is my product a medical device?) and classification (determination risk class) of medical devices;
  • Perform risk analyses in accordance with EN-ISO 14971;
  • Set up quality management system in accordance with EN-ISO 13485;
  • Conduct product testing in accordance with EN 60601 standards;
  • CE marking of medical software and applications in accordance with EN 62304 and/or EN 82304;
  • Assessment of general safety and performance requirements;
  • Draw up (post-market) clinical evaluations;
  • Establish post-market surveillance and vigilance system;
  • Verification of Technical Documentation;
  • Verification of instructions, labels and markings (safety information) in accordance with EN 1041 and EN-ISO 15223-1;
  • Operate on your company’s behalf as European Notified Body and/or Authorizd Representative;
  • Advice on the registration of medical devices (UDI) and market participants in EUDAMED.

Six steps to CE marking of Medical Devices

01Qualification and classification of a medical device

Present substantiated qualification and justify classification of a medical device.

02Design a risk management system

The risk management system will be designed and implemented in accordance with EN-ISO 14971.

03Implement a quality management system

The quality management system is designed and implemented in accordance with EN-ISO 13485.

04Compile Technical Documentation

Including, among others, the general safety and performance requirements, the clinical evaluation, post-market surveillance procedure, instructions, labels and marking.

05Consultancy services regarding registration obligations

Registration of accessories (UDI) and market participants. Designate Notified Body responsible for compliance

06Draw up EU declaration of conformity and affix CE marking

Draw up the EU Declaration of Conformity and provide instructions for affixing the CE Marking in accordance with the requirements of the Medical Devices Regulation.

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