In Vitro Diagnostic Medical Devices
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.
Under Directive 98/79/EC
- What is an in vitro diagnostic medical device (IVDMD)?
Directive 98/79/EC, Article 1, defines IVDMDs as follows:“in vitro diagnostic medical device”: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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:
- concerning a physiological or pathological state,
- concerning a congenital abnormality,
- to determine the safety and compatibility with potential recipients,
- to monitor therapeutic measures.
- Directive 98/79/EC applies to in vitro diagnostic medical devices and their accessories. Accessories are treated as in vitro diagnostic medical devices in and of themselves.
Self-testing devices, specimen receptacles and devices for performance evaluation are also described in Article 1.
- The manufacturer is legally responsible for marketing a device that conforms to essential requirements, listed in Annex I of the Directive. The manufacturer affixes the CE marking on the device and draws up an EC declaration of conformity before putting their IVDMD on the European market.
If the manufacturer is located outside of Europe, it appoints an Authorized Representative. This Authorized Representative must be established within the European Union.
- The participation of a notified body, under the terms of this Directive, is required for the devices listed in Annex II of Directive 98/79/EC and for self-testing devices regardless of their intended purpose.
- IVDMD classification is established as laid out in Annex II with Lists A and B
Devices classified in Annex II, List A are devices of high risk to public health and to the patient, those in Annex II, List B are of moderate risk to public health and high risk to the patient.
Examples of device types and classification:
Annex II, List A: device for screening
- Devices for determining ABO system, rhesus, anti-Kell blood types
- Devices for detecting markers of HIV infection, HTLV and hepatitis B, C and D
Annex II, List B
- Devices for detecting the following congenital infections: rubella, toxoplasmosis
- Devices for diagnosing hereditary disease: phenylketonuria
- Devices for determining human cytomegalovirus, chlamydia infections
- Devices for self-testing to measure blood sugar
GMED is a notified body under Directive 98/79/EC and Regulation (EU) 2017/746, registered under number 0459. The scope of GMED’s notification is available on the European Commission website : New Approach Notified and Designated Organisations NANDO
New Regulation (EU) 2017/746
- 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:
- 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.
- 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.
- 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.
- 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
- 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).
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