New In-Vitro Diagnostic Medical Device Regulation (IVDR)
According to the new IVD Regulation (2017/746) mechanical and electronic pipettes and pipette tips are classified as products for general laboratory use that can be also used to perform in-vitro diagnostic procedures but do not fall under the scope of in-vitro diagnostic medical devices, unless such products, in view of their characteristics, are solely intended and promoted by their manufacturer to be used for in vitro diagnostic examination in association with specific reagents and/or apparatus.
In 2022 the IVD Regulation (2017/746) replaces the IVD Directive (98/79/EC) under which Sartorius pipettes and pipette tips were registered as IVD product. Under the IVD Regulation (2017/746) mechanical and electronic pipettes and pipette tips are classified as products for general laboratory use. They can be used to perform in-vitro diagnostic procedures, but do not fall under the scope of in-vitro diagnostic medical devices.
Regulatory framework and application
Currently, the IVD Directive, and soon the IVD Regulations, provide the regulatory framework for manufacturers and for authorized representatives who wish to place in vitro diagnostic (IVD) products on the EU market. Products that satisfy the regulatory requirements are permitted to carry the CE IVD mark. Dual-use products that can be used both in general laboratory use and in vitro diagnostics are not solely and specifically intended for use in in-vitro diagnostic examination and thus are not allowed to be affixed with the CE IVD mark.
In practice this requires CE IVD marked pipettes and pipette tips to be an irreplaceable part of the in-vitro examination. To comply with the upcoming regulations Sartorius will remove the CE IVD marking from pipettes and pipette tips and the relevant documentation like product labels, technical specification sheets, technical manuals and future marketing material.
Changes and products
Sartorius will remove CE IVD markings from certain pipettes and pipette tips. Electronic pipettes will remain to be CE marked based on electrical safety directive (IEC 61010-1 ed. 3.0 2010-06) and electromagnetic compatibility directive (EN 61326:2013). Sartorius will continue to provide our products with unchanged design and performance as up to now but without the CE IVD marking.
For more information on the changes, read Sartorius official notification letter.