Quality

produces and develops in vitro diagnostic medical devices for the diagnosis of infectious and autoimmune diseases.

With regard to our customer’s satisfaction, a reliable diagnostic and hence patient’s well-being we set a high value on good quality.

We have therefore established a quality management system according to DIN EN ISO 13485. Periodically audits help to maintain and improve our system.

Status regarding IVDR (Regulation (EU) 2017/746)

Regulation (EU) 2024/1860:

In the framework of this regulation amending regulation (EU) 2017/746 (= IVDR) – including but not limited to - the transitional provisions for certain in vitro diagnostic medical devices have been re-defined subject to the manufacturer’s continued compliance to the other conditions specified in Article 110.3b of IVDR (as amended by Regulation (EU) 2024/1860).

NBCL Notified Body Confirmation Letter:

This letter confirms that mdc Stuttgart, Germany has received a formal application regarding the certification according to the regulation (EU) 2017/746 = IVDR and has signed a written agreement with ravo Diagnostika.

Further this letter confirms – including but not limited to - the appropriate surveillance in the framework of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746

The devices covered by the formal application and the written agreement mentioned above are identified in the Tables 1 and 2 of the confirmation letter.

The transition timelines that apply to the devices covered by this letter, subject to the manufacturer’s continued compliance to the other conditions specified in Article 110.3b of IVDR (as amended by Regulation (EU) 2024/1860), are shown below:

• 31 December 2027 for the ToxoTool A-I und den ToxoTool M-I ISAGA see table 1
• 31 December 2028 for the PNS Line Assays und PNS DIVER Assays (class C devices) see table 2
• 31 December 2029 for the indirect haemagglutination assays (class B devices) see table 2

Our quality management system and hence our success are supported by our qualified team. A flat hierarchy is responsible for a good and joyful working atmosphere, good communication and identification with our companys’ objectives.