Regulations

MDR and IVDR

Our cell sampling devices are classified under (EU) MDD or (EU) MDR classification.

Despite this we often get the question whether they also fall under the (EU) IVDR.  As mentioned in the (EU) IVDR Chapter I, Section 1, article 1 point 3 (see below) the regulation does not apply to our products (see B).

3. This Regulation does not apply to:

(a)     products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are                            specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(b)    invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;

(c)      internationally certified reference materials;

(d)      materials used for external quality assessment schemes.

 

Quality Certificates

Certificate DIN EN ISO 13485

EC-Certificate acc. 93/42/EEC Annex II

TUV USA ISO 13485:2016 (MDSAP)

U.S. FDA

Go to the FDA 510(k) database:
510(k) numbers