DeviCE Sistemas

Health Product

MDR and IVDR Health Product.

normas europeas

CE Marking

The CE Marking process for Medical Devices or in vitro diagnostic medical devices requires exhaustive knowledge of the European Medical Device Regulations Regulation (EU) 745/2017 MDR or Regulation (EU) 746/2017 IVDR for a correct interpretation of the requirements. deviCE Sistemas, has specialists in this whole process, from the classification of the Medical Device or In Vitro Diagnostic Medical Device to the preparation of the technical documentation, the conformity assessment and the registration of the product.

The implementation of the ISO 13485 Quality Management System is an essential requirement for manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices and very necessary for other economic agents such as importers of Medical Devices, distributors of Medical Devices, sterilisers or groupers of Medical Devices.

deviCE Sistemas also carries out the necessary procedures with the Notified Body chosen to carry out the conformity assessment for those Medical Devices whose classification requires it. We are aware of the difficulty of choosing a Notified Body and for this reason, we offer different options depending on the needs and characteristics of our client.

The regulation of medical devices and in vitro diagnostic medical devices is not only focused on compliance with the requirements set out in the above-mentioned Regulations, but there are a large number of Harmonised Standards published in the Official Journal of the European Union (OJEU) that deserve attention. Harmonised Standards are not mandatory, but their use demonstrates compliance with one or more applicable legal requirements.

Economic actors involved in the life cycle of the medical device, especially manufacturers, need to be aware of the Harmonised European Standards that apply to the design, development, manufacture, preservation, distribution, and destruction of their medical device so that they can demonstrate compliance with all the legal requirements that apply to them at each stage of the life cycle.

deviCE Sistemas has experience in identifying the harmonised standards applicable to each medical device and in implementing them as required.

Non-Harmonised European Standards, i.e. not published in the OJEU, may also be applicable for the fulfilment of General Safety and Performance Requirements (GSPR) required by the Regulations, if they are relevant to the requirement to be fulfilled.

Equally, International Standards such as ISO or IEC standards may be applicable in order 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 met to satisfy a legal requirement.

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However, it is important to be aware that not all Standards have the same impact on compliance with a legal requirement. Below is a scheme indicating the ranges of identification of the importance of standards:

The identification of European Standards for the satisfaction of legal compliance (GSPR) is the first step in the compliance process. The study of the standards, their analysis and adaptation to the specific needs of the characteristics of the product and the company is the work that deviCE Sistemas carries out for its clients. Finally, it is a matter of demonstrating that the Manufacturer, Importer or Distributor of Medical Devices and Medical Devices for In Vitro Diagnostics carry out their work in continuous compliance with the regulatory and product requirements, achieving optimum safety and quality of the same.

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 has to be developed in the Technical Documentation,

but it is the Notified Bodies who determine how the different documents should be presented.

deviCE Sistemas has experience in the drafting of Technical Documentation for medical devices in compliance with the requirements of the Notified Bodies.

The last step in the marketing 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’s data, UDI, clinical research data, etc. etc. but the manufacturers in each EU country must also register the medical devices in their respective agencies, so that the competent authority grants the approval for the product in question to be marketed in the EU.