Scope: |
This ESSENTIAL describes the regulatory requirements of In-Vitro Diagnostics medical devices in the European Union, based on the
- Regulation (EU) 2017/746 and its amendments
- MDCG (EU Medical Device Coordination Group) documents
Definition of "‘In-Vitro Diagnostic medical device" acc. to Article 2 of Regulation (EU) 2017/746:
"In-Vitro Diagnostic medical device" means 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 with potential recipients;
e) to predict treatment response or reactions;
f) to define or monitoring therapeutic measures
IVD products are classified into four risk classes, according to the risk associated with their use.
ANNEX VIII - CLASSIFICATION RULES, Chapter 2, Rule 1 - 7.
Class A
Class B
Class C
Class D
Not in scope of this CRF:
- Medical Devices (see: ESSENTIAL EEA Medical Devices)
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Legislation in force: |
Regulation (EU) 2017/746 repeals:
- Directive 98/79/EC
- Commission Decision 2010/227/EU
All cited Articles are part of the Regulation (EU) 2017/746.
Regulation (EU) 2017/746, Article 110 is amended as follows:
Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the
involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in
accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation
requires the involvement of a notified body, may be placed on the market or put into service until the following
dates:
a) 26 May 2025, for class D devices;
b) 26 May 2026, for class C devices;
c) 26 May 2027, for class B devices;
d) 26 May 2027, for class A devices placed on the market in sterile condition
Regulation (EU) 2017/746 is amended as follows:
(1) in Article 110, paragraph 4 is replaced by the following:
4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.;
(2) in Article 112, the second paragraph is replaced by the following:
As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.
Scope of this amending Regulation:
Article 40 - Monitoring and re-assessment of notified bodies
- the timing of the first complete re-assessment of a notified body after notification has been extended to 5 years (former: 3 years)
- the frequency of subsequent complete re-assessments has also been extended to 5 years (former: 4 years)
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Comment on the comparability to EU legislation: |
not applicable... |