EN 13612 Test for In Vitro Diagnostic Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 13612 testing. This standard applies to the performance evaluation of in vitro diagnostic medical devices, including IVD MDs for self-testing.

It specifies the responsibilities and general requirements for planning, conducting, evaluating and documenting a performance evaluation study by the manufacturer. It does not apply to certain IVD MDs or certain assessment plans for a particular use.

Where a manufacturer maintains a quality system, this standard addresses compliance with "design verification" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928, with particular regard to the nature and use of IVD MDs.

In particular, this standard applies to IVD MDs:

• Provide evidence to notified bodies and national authorities based on the results of the performance evaluation performed by IVD MD as requested by the manufacturer,
• generate adequate performance appraisal data from appropriate studies or available literature; and
• Quality system for design verification.

EUROLAB assists manufacturers with EN 13612 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.