Quality Management System /
IVDR Regulation /

QUALITY MANAGEMENT SYSTEM

PRIMA Lab SA Quality Management System is compliant with ISO 13485:2016 requirements. All these certificates have been issued by mdc (Medical Device Certification).

ISO 13485:2016 is an international standard which specifies the requirements for the Quality Management System in place in the organizations involved in the manufacture of medical devices and related services that meet customer and regulatory requirements.

QUALITY POLICY

Offering innovative services and products in order to meet the expectations and requirements of customers in compliance with mandatory regulations, using a chain of qualified and experienced suppliers.
Adoption of the Quality Management System as main company tool in business management and in the management of continuous improvement, as a point of reference for the management of the company and its customers.
The compliance of products and services with applicable laws and technical standards is a priority for the company, which is also taken into account in marketing actions as a factor of competitive advantage on the market.
Preserving the following values: “Passion, Cooperation, Quality” which form the foundations of the Company’s culture and are key areas of focus across all functions of the business.

HOW PRIMA IS FACING THE EU IVDR REGULATION?

PRIMA Lab SA’s Quality and Regulatory departments are committed to giving our customers and partners the best support during the transition to the new In Vitro Diagnostic Medical Device Regulation (IVDR), which came into force on May 25, 2017 and was applied on May 26, 2022. In the light of the recent implementation of the Reg. EU 2017/746 (IVDR) and given the importance and strategic impact of this Regulation on our business, we would like to share some key points about the PRIMA Lab SA transition plan to IVDR 2017/746:

  • PRIMA Lab SA confirms that our IVD products covered by the applicable transition provisions can continue to be placed on the market during the IVDR transition period. In accordance with Regulation (EU) 2017/746, as amended by Regulation (EU) 2024/1860, and confirmed by our Notified Body Confirmation Letter, the transition period extends up to 31 December 2027 for our Self-Testing line and up to 31 December 2028/2029 for our Professional line, depending on the applicable device classification. This ensures continued availability of our products while the transition to full IVDR compliance is completed.

  • PRIMA Lab SA has successfully implemented its quality system to comply with applicable IVDR requirements.

  • PRIMA Lab SA, as legal manufacturer, appointed an EU authorized representative to comply with requirements of Economic Operators highlighted in the IVDR

  • PRIMA Lab SA will maintain the current notified body Mdc for the CE marking process. Mdc 0483 has now been designated for IVDR and notified on NANDO as a Notified Body for IVDR services on Feb 16, 2023.

  • The IVD devices will be gradually CE marked according to IVDR based on a transition plan agreed with the Notified Body.

  • PRIMA Lab SA is registered in EUDAMED (CH-MF-000034473) and SWISSDAMED (CHE301179156) and manages device and UDI information in accordance with applicable European and Swiss regulations, ensuring transparency, traceability and regulatory compliance.

Our mission is to give you the best support to face the regulatory challenges emerged in the market