Frequently Asked Questions

Why MicroVal?

• MicroVal is an open platform all European Certification Bodies to provide a single system
• aiming at a harmonized interpretation of the EN ISO 16140
• working towards a harmonized global market for all test kits
• headed by one European platform with all stakeholders involved
• a neutral MicroVal secretariat

How do I become MicroVal certified?

There are a number of steps involved.

• The manufacturer presents a request to any MicroVal Certification Body (MCB).
• When accepted, the validation study of test method is performed by an Expert Laboratory which organises a preliminary study and then a collaborative study involving at least 8 (for quantitative methods) or 10 (for qualitative methods) collaborative laboratories from 3 different countries.
• The final decision is taken by the MCB. The MV secretariat is informed of this decision.
• If the certification is not granted the manufacturer can appeal to the MGC.
• If the method has already been validated and/or certified by another organisation, specific rules apply in order to consider such results.

Does MicroVal Certification conform to EU requirements?

Micro Val Certification conforms to EU requirements as follows:

• MicroVal validation is performed against a CEN method or ISO method as stated in Annex 1 (of Commission Regulation (EC) 2073/2005) or if no CEN/ISO is available a European official method
• Validation is granted by third party certification bodies (e.g. Lloyd's Register QA)
• Validation is in accordance with the protocol set out in EN/ISO standard 16140 - Protocol for the validation of alternative methods

Therefore alternative methods certified with the MicroVal organisation fulfills the requirements as stated in the European Commission regulation.