The EU MDR standard is basic for the professional group involved in the marketing of medical devices. From manufacturers, authorized representatives, importers, or distributors of medical devices in the European Union (EU). These professionals must be up to date with compliance with this standard. This standard is subject to updates derived from the work carried out within the European Union. Thus, in October 2018, the EU Commission gave the green light to the new MDR and IVDR implementation measures plan. This plan includes standards that involve new assessments in the medical device industry. Below we detail the most relevant requirements of this sanitary standard.

EU MDR 5 essential requirements

  1. Definition of use or purpose of the medical device (Article 2 of the MDR). This article talks about the need to document the purpose of the product and check that it falls within the definition. Thus, it is established that it is essential that they do not develop their main action as expected inside or on the surface of the human body through pharmacological, immunological, or metabolic elements.
  2. Risk classification. In this sense, Annex VIII of the MDR establishes 22 rules. The definition of the risk of the product is derived from the application of these rules. It is noted that an incorrect definition of the risk classification implies the wrong choice of the conformity assessment process.

Conformity assessment process

  1. Conformity assessment process. This evaluation process is regulated in Article 22 of this European legal standard. It is established as an essential requirement that the manufacturer follows the procedure set in the article mentioned above.
  2. Device security. This regulation is committed to guaranteeing the safety of the sanitary device as one of the essential standards to be able to market it in the market. In this sense, the product’s design has to follow the established standards to offer safety per the most current knowledge of medicine. Other requirements include performance, use, or safety. As well as the importance of the verification of each part of the process to ensure compliance with the regulations. Ultimately, it is about finding a design that is effective and respectful of sanitary standards.
  3. Technical documentation. One part of the process to authorize the distribution of a medical device refers to technical documentation. In this sense, Annex II of the MDR refers to the requirements that this documentation must meet. This annex relates to the department where this documentation has to be sent to be verified if it meets the requested requirements. This documentation is required to be presented clearly, precisely, and clearly. This is required in this way because it is considered an essential requirement that it be in an auditable and organized format, in a clear way, so that it can be easily consulted. This documentation must comply to certify that the device is safe and that it must comply with all the requirements demanded by European regulations.

IP Triana

At IP Triana, we are aware of the importance of complying with the European Union regulations. In this sense, our processes and protocols for production and verification of the final product quality are very demanding. We work with high-quality standards to offer our customers the most competitive products on the market and facilitate their adaptation to the regulations on health regulation. We are at your disposal to bring our devices to your facilities. Contact us. We will be delighted to assist you.


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