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The Medical Device Developer's Guide to IEC 60601-1

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Medical Devices Regulations (2017/745)

The Medical Devices Regulations covers the regulatory requirements of the European Union for Medical Devices.

Compliance with the requirements of the Medical Devices Regulations is declared by placing the CE Marking on the product, and supplying the device with a Declaration of Conformity.

The routes to compliance depend on the classification of the product. (Note that the full classification rules are given in Annex VIII of the Medical Devices Regulations).

Class I devices are low risk. Examples are stethoscopes, hospital beds, wheelchairs. The manufacturer has to produce a technical file, including product test results to relevant standards. In addition, manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.

Class IIa are low-medium risk devices, with examples such as hearing aids, electrocardiographs, ultrasonic diagnostic equipment. As for Class I, the manufacturer produces a technical file, but in addition a conformity assessment must be carried out by a Notified Body, according to one of the following routes (at the manufacturer's choice):

  • Full quality assurance system (ISO 13485)
  • Production quality assurance system
  • Production verification

Class IIb are medium-high risk devices, with examples such are surgical lasers, infusion pumps (non-implantable), ventilators, intensive care monitoring equipment. Routes to compliance are:

  • Full quality assurance system (ISO 13485)
  • Type examination and product conformity verification

Class III devices are high risk. Examples are balloon catheters, prosthetic heart valves. Routes to compliance are:

  • Full quality assurance system (ISO 13485)
  • Type examination and product conformity verification

Most of the routes to compliance above require the involvement of a Notified Body. A Notified Body is an organization appointed by the national accreditation authorities and "notified" to the European Commission to approve products covered by the Medical Devices Regulations.

For all Classes a Technical File must be prepared, demonstrating compliance of the device with the regulations' essential requirements. Compliance can be assumed by showing conformity to the appropriate standards listed by the European Union as Harmonised Standards for the Medical Devices Regulations.

Products shipped must bear the CE marking to show compliance with the regulations. If a Notified Body is involved in the approval, the number of the Notified Body must also appear adjacent to the CE marking.

Additionally, the product must be shipped with a Declaration of Conformity.




Medical Devices Regulations

Technical File



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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard .

All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication. The material is reproduced or rewritten with their permission.