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After a transitional period that has lasted several months and in which the European institutions, the EU reference laboratories or EURLs and the notified bodies have worked in a coordinated manner, today begins the application of the new European regulation on in vitro diagnostic medical devices: Regulation 2017/746 or IVDR.
In vitro diagnostic medical devices or IVDs include any medical device consisting of a reagent, reagent product, calibrator, control material, kit, specimen container, instrument, apparatus, piece of equipment, software or system, used alone or in combination, intended by the manufacturer to be used in vitro for the study of specimens derived from the human body, including blood and tissue donations.[1]
IVDs are also divided according to risk into class A, B, C, and D, with class D products presenting the highest risk, which is why it has been agreed that the IVDR should be applied first to products in the latter group.
Thus, Class D IVDs must be verified by a EURL in order to obtain certification and subsequent CE marking. With this, the European Commission seeks to ensure that the placing on the EU market, marketing and putting into service of these medical devices takes place with all the health and quality guarantees for the citizens of the European Union. Until now, 90% of these products were marketed in Europe only by means of self-assessments.
CQS has received the EURL designation to evaluate two categories of Class D IVDs: (i) IVDs intended for the detection or quantification of herpes virus markers, and (ii) IVDs intended for the detection and quantification of markers of bacterial infections.
In addition to the above-mentioned verification tasks, EURLs will also be responsible for compliance with common specifications; analysis of samples or batches, advice to selected European and domestic institutions, and recommendation on reference materials and measurement procedures, among other actions.
“Those of us at CQS were very proud to receive the designation as an EU reference laboratory last year, coinciding with our 20th anniversary. Therefore, we have been preparing responsibly to meet this challenge.” This was stated by Dr. Juan José Álvarez Millán, CEO of CQS, who also highlighted the creation of a networking group with members from all designated EURLs in order to harmonize verification processes.
The new system, explained Dr. Álvarez Millán, “will serve to provide greater security and transparency, but also more legal clarity for companies”. Not surprisingly, the transitional periods for some legacy devices have also been extended, allowing manufacturers more time to comply with the new IVDR requirements. This is crucial to ensure a smooth transition and avoid disruptions in the supply of essential products.
He also expressed his confidence that having reference laboratories will be a further step in favor of the health of all Europeans. “We hope that this milestone will contribute to progress towards a European Health Union that will enable, as the European Commission has pointed out, all member countries to be prepared to respond jointly to health crises and to have innovative and reliable health products,” he said.
More information on the designation as well as scope, methodology, processes and fees here.
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[1] Specifically, Regulation 2017/746 states that these in vitro diagnostic medical devices shall be intended to collect information on all or some of the following: a) relating to a physiological or pathological process or condition; b) relating to congenital physical or mental deficiencies; c) relating to predisposition to an ailment or disease; d) to determine safety and compatibility with potential recipients; e) to predict response or reaction to treatment; or f) to establish or monitor therapeutic measures.