Medical devices and in vitro diagnostic medical devices may only be placed on the market or put into service if they meet the essential requirements specified in the new Medical Device Regulation (MDR). Depending on the manufacturer’s registered office/authorized representative and the type of product, the respective authority and notified body must be involved in the notification and conformity assessment procedures.

First, a medical device must be assigned to one of the four risk classes. Afterwards, technical documentation for the proof of safety and clinical documentation for the proof of performance and efficacy have to be prepared. Depending on the risk classification, either the company itself (self-certification for Class I) or a notified body checks the safety and performance. In some cases (class III), the BfArM is also consulted within the scope of a consultation procedure if the medical device contains parts of pharmaceuticals.

CE marking is required before a medical device can be placed on the market for the first time.  A written declaration of conformity must be submitted to receive CE marking, and a notification must be made to the competent authority.

In the phase of market surveillance, the state authorities are responsible for monitoring the medical device on the market and at the manufacturer. The manufacturer has been made responsible by the new medical device regulation (MDR) for the long-term monitoring of his product, which is carried out and documented by clinical studies, registers, safety and metrological controls, among other things.

In the downstream re-audit phase, an annual re-audit of the quality management system by the notified body and a re-certification of the medical device by the notified body is required at least every 5 years.

The current classification rules are laid down in detail in Annex IX of EU Directive 93/42/EEC. The application of the classification rules depends on the intended purpose of the devices and is the manufacturer’s responsibility.

According to the classification rules, medical devices are divided into four risk classes: I, IIa, IIb and III (depending on the risk during use). In addition, there are the subclasses Is (sterile class I devices) and Im (class I devices with a measuring function).

A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These notified bodies are inspection bodies according to uniform European criteria, which audit and certify the manufacturer’s conformity assessment procedure.

This gives the manufacturer a temporary authorization to issue the declaration of conformity and affix the CE marking. The requirements for designation and notification are now governed by Chapter IV (Art. 35-50) of the MDR. All notified bodies are published on the NANDO homepage.

European Commission / NANDO – List of notified bodies

Before you can launch a medical device for use for patients, you have to guarantee that it works safely. Therefore each manufacturer of a medical device needs to perform tests and document for performance and safety and show that the benefits of using it outweigh any potential risks. For the sake of patient safety, implanted devices and devices in risk class III must be subjected to clinical investigation, including where appropriate testing in humans.

These investigations are included in a risk analysis and a clinical evaluation, which are key elements of the manufacturer’s technical documentation to certify the performance and safety of the device. If the device belongs to the medium- to high-risk classes (IIa, IIb and III), the technical documentation of the device must be reviewed and assessed by external experts in a so-called notified body.