The start point is to stablish your device classification:

This is agood description  (

  • Class I Devices – Non-evasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File.
  • Class Is Devices – Class Is devices are similarly non-evasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.
  • Class Im Devices – This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-evasive blood pressure measuring devices. Once again the manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations.
  • Class IIa Devices – Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and a conformity test carried out by a European Notified Body.
  • Class IIb Devices – Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identicalcompliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body.
  • Class III Devices – Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device’s design and the device itself by a European Notified Body.

Then, based on the classification choose the path to seek CE approval (Annex). This will determine some additional requirements.

You can find some inforamtion here:


As part of the CE marking, you need a technical file, which has to contain

Now, with the new Medical device regulation (MDR) you no longer have a list of essential requirements, but have to demonstrate that you meet the “general requirements”


Here is where you should use the “harmonized standards” to demonstrate that your product is safe and fit for purpose. The MDR says that using a standard “should be a means”, I underrated that means that is not the only way:

In the “technical file”, now called “technical documentation” is where the reference to those standards can be used:



There is a big list of harmonized standards:

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