Launching a medical device in the European Union is possible only if it undergoes a conformity assessment. This official procedure proves a device manufacturer is offering a safe product with desired performance through an examination of its compliance with legal requirements. Medical electronics manufacturing regulations are applied to all of the entities producing devices for healthcare even if their contribution is limited.
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Toggle Table of ContentMedical electronics manufacturing regulations in EU
After a four-year transition period, on May 26, 2021, The Medical Devices Regulation (Regulation (EU) 2017/745) started applying. The In-Vitro Diagnostic Devices Regulation (Regulation (EU) 2017/746) has been enforced since May 26, 2022, as this new set of rules had a five-year transition period.
These regulations replaced Directive 90/385/EEC for active implantable medical devices and Directive 93/42/EEC for medical equipment.
Thus, for an electronic device designed for healthcare purposes to be placed on the European Union market, the CE (Conformité Européenne) mark is required, which can be used exclusively by the medical electronics manufacturing services (EMS) complying with the new regulations.
Obligations for medical electronics manufacturing services
Medical electronics manufacturing regulations have several requirements for any manufacturer who takes part in the production of a medical device. The list of obligations includes any action that can contribute to the safety of end-users.
Thus, medical electronics manufacturing services have to invest in effective management systems for quality and risk assessment. They now have to mark all of their products with special unique identification codes (UDI). Products have to undergo clinical evaluation and have extensive technical documentation.
Furthermore, manufacturers of medical devices are responsible for the supervision of their products after their launch.
Meeting requirements for medical EMS – key standards
Since the best proof of the conformity with these regulations is the possession of related ISO certificates, a recommended way of outsourcing production is to use the assistance of medical EMS providers with such certificates.
While the paramount standard is ISO 13485 for a medical device quality management system, there are also three additional standards for a quality management system (ISO 9001), continuity management system (ISO 22301) and environmental management system (ISO 14001). Assel possesses all of these certificates.
Medical device manufacturing – conclusions
The new medical electronics manufacturing regulations are earmarked not only for the Original Equipment Manufacturers but also for medical EMS providers. The ISO certificates held by Assel guarantee it meets the requirements for medical device production including systems for risk management, validation and traceability.