In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

All in vitro diagnostic medical devices which are sold on the European market are required to bear the CE mark. The CE mark indicates compliance with the applicable European legislation. From the 26h of May 2017 the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 has entered into force. This Regulation replaces the In Vitro Diagnostic Medical Devices Directive 98/79/EC. As there is a transitional period of five years, until the 26^th of May 2022, both the Regulation as the Directive are available. The Directive will be revoked after the transitional period.

Responsibility

The manufacturer of an in vitro diagnostic medical device is responsible for the compliance of the medical device with the applicable European legislation. The manufacturer shall therefore ensure to carry out the correct conformity assessment procedure or let it be carried out. When the in vitro diagnostic medical device is in compliance, the manufacturer shall apply the CE mark on the device.

Authorized Representative

When the manufacturer of an in vitro diagnostic medical device is not established in a Member State of the EU, he shall designate an AR within the EU before placing the devices onto the European market.

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Classification of in vitro diagnostic medical devices

Not every in vitro diagnostic medical device is the same and should therefore also not be treated as one entity. Therefore, the European Commission divided in vitro diagnostic medical devices in different classes. The different classes are divided by the intended purpose and the inherent risks. The different classes shall go through a different conformity assessment procedures. The classes are divided from class A to D.

The following classes are identified in accordance with the In Vitro Diagnostic Medical Devices Regulation.

Class A, e.g. products for general laboratory use.
Class B, e.g. pregnancy tests.
Class C, e.g. products for detecting the presence of a sexually transmitted agent.
Class D, e.g. products for detecting the presence of a transmittable agent in blood, in order to assess their suitability for transfusion.

Conformity assessment procedure

In order to indicate compliance of the in vitro diagnostic medical device with the applicable European legislation the correct conformity assessment procedure must be carried out. The conformity assessment procedure depends on the classification of the medical device. Below you can find the different conformity assessment procedures for the in vitro diagnostic medical devices in accordance with the different risk classes.

Technical Documentation

Manufacturers of in vitro diagnostic medical device must ensure to have the required Technical Documentation in order regarding their in vitro diagnostic medical device. The Technical Documentation entails all documentation which can be used to determine the compliance of the in vitro diagnostic medical device with the applicable European legislation. The Technical Documentation entails minimally the following.

Device description and specification (e.g. UDI, risk class, technical specifications etc.).
Information regarding the labels and packaging.
The instructions for use.
Information regarding the design and manufacturing.
Information regarding all production sites.
Documentation demonstrating compliance with the general safety and performance requirements.
The benefit-risk analysis.
Documentation on product verification and validation (e.g. claimed shelf-life, in-use stability, software verification and validation etc.).
Documentation on post-market surveillance.

Quality Management System

When medical devices are manufactured, they are often manufactured in series. In order to ensure the compliance of all the medical devices produced in series with the applicable European legislation, it is required to manufacturers to implement a Quality Management System (QMS). In this way the presumption of conformity is determined of all the medical devices produced in series.

Compliance with the In Vitro Diagnostic Medical Devices Directive 98/79/EC

During the transitional period until May 26^th, 2022, it is legally possible for manufacturers of in vitro medical devices to comply with the In Vitro Diagnostic Medical Devices Directive 98/79/EC. You can read more about the transition from the In Vitro Diagnostic Medical Devices Directive 98/79/EC here.