ESI is a recognized company for regulatory consultancy and support during the compliance and registration process of medical devices (MDs). Our highly qualified technical team, both locally and internationally, can provide specific regulatory advice for EU and US countries.


Regulation (EU) 2017/745 of April 5, 2017, on medical devices, and Regulation (EU) 2017/746 on injectable medical devices introduce significant changes to the entire sector on many key topics of the regulatory system, such as:

  • Expansion of the scope;

  • Product traceability process;

  • Structure and contents of technical documentation;

  • Strengthening of market surveillance and supervision, conducting clinical investigations, and extending obligations to importers and distributors.

ISO 13488:2016 specifies requirements for quality management systems of organizations operating in the design and production of medical devices, as well as the design and provision of related services. It applies to:

  • Manufacturers of devices subject to CE Marking (all MD classes);

  • Suppliers of special processes associated with device production (sterilization, storage, transportation)

  • Companies distributing and marketing medical products;

  • Companies providing services related to devices (installation, maintenance and repair, clinical engineering).

ISO 13485:

  • Focuses on effective use of feedback information to ensure safety and performance requirements throughout the device lifecycle;

  • Emphasizes the need for “Usability” evaluation of medical devices;

  • Considers the roles and responsibilities of different parties in the device lifecycle, such as suppliers, logistics service providers, distributors, importers, etc.;

  • Recognizes service providers, processes, and semi-finished products as important subjects in the device manufacturing cycle;

  • Introduces design transfer requirements;

  • Imposes post-market product monitoring with new requirements;

  • Requires validation of software used in quality management systems and software involved in production and service delivery processes;

  • Highlights risk-based approach in process management.

The U.S. FDA is working on harmonizing 21 CFR 820 with ISO 13485 to modernize and standardize regulations in this sector.


Discover ESI’s support and consultancy services for the Medical Device industry, including training, 1st and 2nd party audits, regulatory agency inspection support, development and updating of technical files for medical devices, and registrations.

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