BIRR’s CE Marking: Your Guarantee for Safe and High-Quality IVF Labware

What is the Medical Device Regulation (MDR) and how does it contribute to patient safety?

IVF labware products come into contact with cells, such as embryos and gametes. You must therefore be assured that the products are safe. But how do you know? You cannot see this from the outside. The MDR was introduced for this purpose and defines the general safety and performance requirements for medical devices as a European regulation to increase patient safety. It sets requirements for the design of products, but also for the manufacturing and the information provided. By drawing up an EU declaration of conformity, the manufacturer takes responsibility for the devices meeting the requirements of the MDR. Devices that comply with the MDR must be provided with a CE mark.

“The CE marking is proof that BIRR’s IVF Labware complies with the strict requirements of the European Medical Device Regulation (MDR) and is safe to use in your clinic.”
Tom Vermeiden CEO BIRR

Download of Quality Certificates and Technical related documentation: For distributors and customers who need Certificates, QMS, DoC, CoC, Lot related CoA, IFU available to be downloaded in our quality portal. Please click on Quality Portal. You will have to fill in a password (if not available, please contact email).

GO TO QUALITY PORTAL

How do I know if a product complies with the MDR?

In addition to the presence of an EU declaration of conformity, you should pay attention to a number of other aspects:

MD vs IVD

Always check whether the symbol ‘MD’ (Medical Device) is displayed among the symbols in the
IFU (Instructions for Use) and on the product label. There is a big difference between MD and IVD medical devices. Medical devices (MD) are suita- ble for the treatment or process of IVF. IVD stands for In Vitro Diagnostic Medical device. IVD medical devices are intended only for diagnostic purposes outside the human body. IVD medical devices are not intended for clinical use (IVF, ICSI, embryo transfer, etc.). IVD medical devices fall under different, less strict, legislation than the MDR.

CE with (XXXX) and without number

The difference between a CE marking with a number and a CE marking without a number
has to do with the involvement of an independent notified body. The numbers indicate whether a
NB was involved in the assessment and approval of the product. The NB performs tests, inspections and audits to confirm conformity. A CE without
a number indicates that the manufacturer has assessed whether the product complies with the regulations. For IVF Labware (risk class IIa) the involvement of a NB is mandatory.

ISO 13485 certified

The ISO 13485 certification proves that a company meets the requirements regarding the way in which an organization has organized the company, design, development, production and maintenance of IVF Labware.