CE Marking
The process of CE Marking of Medical Device or In Vitro Diagnostic Medical Device requires thorough knowledge of the European Medical Device Regulation Regulation (EU) 745/2017 MDR or Regulation (EU) 746/2017 IVDR for a correct interpretation of the requirements. deviCE Sistemas, (Vitoria-Gasteiz) has specialists in this entire process, which includes everything from the classification of the Medical Device or In Vitro Diagnostic Medical Device, to the preparation of technical documentation, conformity assessment, and product registration.The implementation of the ISO 13485 Quality Management System is a fundamental requirement for manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices and is very necessary for other economic operators such as importers of Medical Devices, distributors of Medical Devices, sterilizers, or assemblers of Medical Devices.
deviCE Sistemas also carries out, for those Medical Devices whose classification requires it, the necessary procedures with the Notified Body chosen for the conformity assessment. We are aware of the difficulty in choosing a Notified Body and for this reason, we offer different options based on the needs and characteristics of our client.The regulation of medical devices and in vitro diagnostic medical devices not only focuses on compliance with the requirements established in the mentioned Regulations, but there is also a large number of Harmonized Standards published in the Official Journal of the European Union (OJEU) that deserve attention. Harmonized Standards are not mandatory, but their use demonstrates compliance with one or more applicable legal requirements.
The economic operators involved in the lifecycle of the medical device, especially manufacturers, must be aware of the European Harmonized Standards that apply to the design, development, manufacturing, preservation, distribution, and destruction of their medical device so that they can demonstrate compliance with all legal requirements applicable to them at each stage of the lifecycle.deviCE Sistemas has experience in identifying the harmonized standards applicable to each medical device and in implementing them as needed.
Additionally, for compliance with general safety and performance requirements (GSPR) required by the Regulations, Non-Harmonized European Standards, meaning those not published in the OJEU, may also be applicable when they relate to the requirement to be met.Similarly, International Standards such as ISO or IEC standards may be applicable to demonstrate compliance with a safety and performance requirement. At the national level, UNE standards, for example, (A Spanish Standard) are standards that can be identified and complied with to address a legal requirement.
We offer you MDR and IVDR medical device services.
However, it is important to know that not all Standards have the same impact on compliance with a legal requirement. Below is a diagram indicating the identification ranges of the importance of the standards:The identification of European Standards for the fulfillment of legal compliance (GSPR) is the first step in the conformity process. The study of the standards, their analysis, and adaptation to the specific needs of the product and company characteristics is the work that deviCE Sistemas performs for its clients. Ultimately, it is about demonstrating that the Manufacturer, Importer, or Distributor of Medical Devices and In Vitro Diagnostic Medical Devices carry out their work in continuous compliance with regulatory and product requirements, achieving optimal safety and quality.
Another important aspect, or perhaps the fundamental one, is the development of the Technical Documentation for each Medical Device or In Vitro Diagnostic Medical Device. The Regulations establish what must be developed in the Technical Documentation, but it is the Notified Bodies that determine how the different documents should be presented.deviCE Sistemas has experience in drafting Technical Documentation for medical devices in compliance with the requirements of the Notified Bodies.
The final step in the commercialization of the medical device is the registration of the Product where applicable. EUDAMED is the European database where it must be registered with all its characteristics: manufacturer data, UDI, clinical investigation data, etc. However, manufacturers in each EU country must also register the Medical Devices with their respective Agencies, so that the Competent Authority grants conformity for the product in question to be marketed in the EU.
