Classification and Regulation

To ensure the safety and effectiveness of medical devices, they are subject to strict regulation. In the European Union, they are classified into four risk categories (Class I, IIa, IIb, and III), with Class III devices representing higher complexity and risk to the patient. All devices must comply with Regulation (EU) 2017/745 (MDR), which establishes criteria for assessment, CE marking, and post-market surveillance.

All devices must comply with Regulation (EU) 2017/745 (MDR), which establishes criteria for assessment, CE marking, and post-market surveillance.

Support for the Medical Device Life Cycle

Companies that develop, manufacture, or distribute medical devices have an increased responsibility to ensure quality, safety, and compliance with all legal requirements. Additionally, they must maintain an ongoing commitment to innovation and improvement of their products and services, always placing the patient's well-being at the center of their mission.

Pharmilab, as a consultant specializing in medical devices, supports these organizations in every steps of the product life cycle — from development and certification to commercialization and post-market surveillance.

We offer technical and regulatory support, ensuring compliance with Regulation (EU) 2017/745 (MDR) and contributing to the implementation of quality management systems, technical files, CE marking, among others.

We help build safer devices, more robust processes, and a more sustainable future for the healthcare sector!