Many laboratories are wondering about the impacts of regulation 2017/746 ( IVDR) on their processes. brings you some possible answers to these challenges. We suggest that you address these issues by product class.

Impact of the IVDR regulation for non-sterile Class A products

Impact for labs is quite limited.

The laboratory must simply collect, if necessary, the EU declarations of conformity of the consumables it uses. Your distributor or supplier must undertake to check these declarations. Indeed, this is his obligation as a distributor or importer. Your supplier / distributor must also undertake to make the declarations of conformity available to you on request from the laboratories.

Impact of the IVDR regulation on laboratories for LGUs that lose the IVD CE marking

The requirement imposed by the regulation is as follows:

– Laboratories must define rules for the acceptance of critical products before use. These requirements are described in NF FR EN norm ISO 15189 :

“ Reagents and Consumables – Acceptance Testing

Each new ready-to-use reagent kit formulation resulting from reagent or procedural changes, a new batch, or a new shipment should be verified for performance before use.

Any consumables that may affect the quality of the exams must be checked for performance before use.”

and NF FR EN norm ISO 17025 :

“6.6.2 The laboratory shall have a procedure and maintain records for:

a) define, review and approve laboratory requirements for products and services provided by external providers
b) define criteria for the evaluation, selection, performance monitoring and reassessment of external providers
c) ensure that products and services provided by external providers comply with the requirements established by the laboratory, or, where applicable, with the relevant requirements of this document, before being used or provided directly to the client;”.

Impacts are therefore of three kinds:

  • The acceptance criteria of a consumable or a reagent are modified where a CE marking was the must-have
  • A documentary revision is necessary, in particular for the receptions procedures, the consumable approval, reception forms, etc…
  • Formalized change via the QMS through an impact study

Several approaches can be considered to control these impacts:

  • Controls at reception of consumables and reagents, or control by sampling, and certificate of conformity of the batch
  • No specific control when the consumables enter the CIQ/EEQ process
  • and all those you may think about already and that may be the best fit for your laboratory !


Impact of the IVDR regulation on laboratories: rely on a partner

You trust your consumables and reagents distributor. He is committed to working with you through this stage of change, and respects the commitments described above.

He can certainly, moreover, propose you adapted and personalized services for your laboratory, including

  • The audit of the current functioning and organization of your laboratory
  • The identification of consumables concerned by the regulation
  • A proposal for an action plan
  • The provision of “procedure models”.

In a few hours, an expert partner in the medical laboratory world can help you take a decisive step.

LABELIANS smart service is at your side to achieve this. If you wish to be supported, if you need help and think about the opportunity to subscribe to a support service for your laboratory, you can contact us for more information.