Logo Enrico Bruno srl

New IVDR regulation (EU) 2017/746

Dear Customer,
as is now known, on May 26 the IVDR Regulation (EU) 2017/746 came into force, which formally replaces the European Directive 98/79 / EC on In Vitro Diagnostic Medical Devices.
The new IVDR Regulation (EU) 2017/746 introduces more stringent and detailed rules on the classification of In Vitro Diagnostic Medical Devices and related accessories, therefore the products listed in Annex 1 do not fall within the scope of application of the aforementioned Regulation.
In fact, according to the new Regulation, products intended for both generic laboratory use and in vitro diagnostic applications cannot be marked "IVDR" .
If these articles were classified as "IVDR" they should be considered an irreplaceable piece with the in vitro examination, which in fact they are not.
In consideration of the above, these items will not have the "IVDR" marking and will be classified as "General Laboratory Use" Devices

However, it is emphasized that they can always be used with human biological samples for any laboratory diagnostic analyzes and in vitro diagnostic applications in all European Community and EFTA countries (Iceland, Liechtenstein, Norway and Switzerland).
In light of the foregoing, the CE-IVD marking will be gradually removed from the items in question (see Annex 1) and the remaining warehouse stocks, already produced, will be sold until they run out.
In any case, we wish to underline that this change will not affect in any way the quality of the items in question , which will continue to be produced with the usual quality standards.
It is also possible that further articles, not better identified at the moment, may be subject to this variation; in this case the guiding criteria of the matter will remain those already highlighted herein.
However, we remain available for any further clarification that may be required.
Sincerely.

ENRICO Bruno srl

Attachment 1

PASTEUR PIPETTE IN PLASTIC

TIPS FOR MICROPIPETTES

TIPS WITH FILTER

LOOP AND STICKS AL FOR MICROBIOLOGY

RODS FOR MIXING / FOR CLOT RELEASE

CONTACTS


ENRICO BRUNO s.r.l.
Via Duino 140
10127 Torino Italy
Tel. +39 011 3160808
Fax +39 011 3160753
PEC pec@pec.enrico-bruno.it
CF/P.IVA: 04891320014

WRITE TO US


For orders, prices requests and offers, technical service commerciale@enrico-bruno.it
For administration service amministrazione@enrico-bruno.it
For Direction – Purchase Department acquisti@enrico-bruno.it

FOLLOW US


Facebook Twitter Blogger