In Vitro Diagnostic Medical Devices
(IVD MD)

Since the mandatory application date of December 7, 2003, all in vitro diagnostic medical devices (IVDMDs) are regulated by Directive 98/79/EC for placement on the European market. Significant changes for all players in the IVDMD market are introduced by the new rules set out in Regulation (EU) 2017/746, which will become mandatory on May 26, 2022.

1. The regulatory changes for in vitro diagnostic medical devices are significant in terms of impact on manufacturers and new obligations for economic operators, notified bodies, Member States and the Commission.
   These changes are described in Regulation 2017/746, published in 2017 and mandatory as of May 26, 2022, for putting all in vitro diagnostic medical devices on the European Union market.
   It is estimated that close to 80% of IVDMD manufacturers will need the services of a notified body for CE marking of their devices. This is a fourfold increase from what is needed under the existing Directive for in vitro diagnostics.
   Examples of noteworthy changes include:

1. The IVDMD definitions set out in Regulation 2017/746, Article 2, were broadened to include:
   • software devices;
   • predisposition to a medical condition or disease;
   • predicting treatment response.

Definition under Article 2:
“In vitro diagnostic medical device,”: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
a) concerning a physiological or pathological process or state;
b) concerning congenital physical or mental impairments;
c) concerning the predisposition to a medical condition or a disease;
d) to determine the safety and compatibility of a given treatment with potential recipients;
e) to predict treatment response or reactions;
f) to define or monitor therapeutic measures.

1. The scope also includes a reference to specimen receptacles, accessories, devices for self-testing but also devices for self-testing used for testing services offered to lay persons, devices for near-patient testing and companion diagnostics.
2. Substantial changes in this Regulation include new obligations for manufacturers, including an obligation for the person in charge of overseeing regulatory compliance, a new joint liability for the Authorized Representative in the event of defective devices and detailed obligations for distributors and importers.
3. Device classification has adopted a risk-based approach in terms of both public health and patient risk, based on the 7 rules laid out in Annex VIII.
   Four IVDMD classes emerge from this, from class A (low risk) to class D (high risk).
   The participation of a notified body, under the terms of Regulation 2017/746, is required for class D, C, B, and sterile A devices, self-testing devices, near-patient testing devices and companion diagnostics.IVDMD classification examples:
   • Class D: HIV screening for blood donations
   • Class C: HLA typing, blood sugar self-testing
   • Class B: antinuclear antibodies, pregnancy self-testing
   • Class A: specimen receptacles

1. The manufacturer documents clinical evidence in a performance assessment report. This report includes the report on scientific validity, the report on analytical performance and the report on clinical performance. The evaluation of these reports enables the manufacturer to demonstrate clinical evidence for the device. To guarantee the safety and performance of the device, a continuous performance evaluation process is laid out that includes reassessment of clinical evidence, particularly with data from post-market surveillance, including post-market performance follow-up (PMPF).