The Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should bring their class 1 medical devices onto the market in compliance with the MDR.

The document is entitled Guidance Notes for Manufacturers of Class I Medical Devices . This article summarizes this document.

1. What distinguishes class 1 medical devices a) Division of medical devices into classes

The Medical Devices Ordinance (MDR) divides medical devices into classes 1, 2a, 2b and 3. This is exactly what the Medical Device Directive MDD does. The classes are often also written with Roman numerals (Class I, IIa, IIb and III).

The classification rules assign higher classes to products with higher risks.

b) Effect of the classification

The classes have no (!) Influence on the basic safety and performance requirements , compliance with which the manufacturer must prove. Rather, the classes determine the conformity assessment procedures in order to demonstrate conformity with precisely these safety and performance requirements.

For medical devices of class 1, no notified bodies need to be involved in the conformity assessment procedure. In addition, the MDR does not insist on the certification of the quality management system by a notified body for class 1 medical devices. Both save time and money.

Medical devices of classes 1s, 1r and 1m are an exception:

  • 1s: Products that are placed on the market in a sterile state
  • 1r: reusable surgical instruments (r stands for "reusable")
  • 1m: Products with a measuring function

For these "1 * products", the manufacturers must involve notified bodies in the conformity assessment.

Additional information

Read more about the classification of medical devices and conformity assessment procedures .

2. How class 1 medical devices are "approved"

The MDCG describes eight steps that manufacturers should go through when placing the product on the market.

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