Information about “grey imports”: Non-IVDR-conform Feather Blades found in the EU-market

pfm medical gmbh (pfmmedical) is the exclusive European distributor, EU authorized representative (EC-REP) and importer of microtome blades for in vitro diagnostics from Feather Safety Razor Ltd., Japan.

We hereby inform you that Feather microtome blades that are incorrectly labeled as CE-conform and incorrectly showing pfmmedical as EC-REP (grey imports), have been found in the European market. These microtome blades do not meet the requirements of the IVDR. They are not intended for the European market and are not correctly labeled as such.

We found forged labeling implying pfmmedical as EC-REP and showing Lot-Numbers that were not assigned for pfmmedical. This labeling is incorrect and applied onto the cellophane packaging.  

IVDR-compliant blades are recognizable by the following:

• information on pfmmedical as EC-REP is printed directly on the box under the cellophane packaging.
• Lot-numbers for IVDR-compliant Feather microtome blades consist of 8 numbers and end with the letter “P”.

pfmmedical has not taken on the role of EC-REP for grey imports.

We want to emphasize there are reasonable doubts about the conformity and marketability of the described products according to IVDR. The distribution of falsely declared Feather Blades in the European market does not comply with the requirements of the IVDR.

pfmmedical, as the EC-REP for Feather Safety Razor Ltd., Japan, reports all violations to the supervisory authorities and the manufacturer as soon as they become known.