Basic requirements for medical devices

The essential requirements for medical devices are key safety and performance requirements that medical devices must fulfil in order to be placed on the market in the EU.

The most important points from Regulation (EU) 2017/745 (Medical Device Regulation, MDR) are as follows:

1. They are set out in Annex I of the MDR as "Essential safety and performance requirements".
2. They replace the previous "Essential Requirements" of the Medical Device Directive (Directive 93/42/EEC, MDD, valid until 2021) and the MEDDEV documents of the European Union for practical guidance on implementation.
3. The main aspects of the Essential Safety and Performance Requirements include
   • Product safety and performanceRisk
   • management
   • Chemical, Physical and biological properties
   • Infection and microbial contaminationConstruction
   • and environmental propertiesProducts
   • with a measuring
   • functionRadiation protectionRequirements
   • for active devices and connected productsInformation
   • from the manufacturer
4. Manufacturers must demonstrate the conformity of their product with these requirements, often by applying further harmonised standards.
5. They form the basis for CE marking and market authorisation of medical devices in the EU.
6. Similar concepts also exist in other countries, e.g. as "Essential Principles" in Australia or "General Controls" and "Special Controls" in the USA, which are defined and regulated by the Food and Drug Administration (FDA) in the Code of Federal Regulations (CFR) Title 21, Parts 800-1299.
7. Compliance with these requirements must be specified in the product's technical documentation.

The essential safety and performance requirements, as defined in Annex I of the EU Medical Device Regulation (MDR), form the foundation for the safety and effectiveness of medical devices and must be met by all manufacturers.

Compliance with these requirements must be demonstrated through appropriate conformity assessment procedures, with the application of harmonised standards or common specifications playing an important role in demonstrating compliance with regulatory requirements.

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