IVDR FAQ

Please utilize our FAQ below for questions relating to IVDR and Biocare Medical’s progress toward compliance. If you have any additional questions, please do not hesitate to contact your local authorized sales representative.

IVDR Frequently Asked Questions

What is In Vitro Diagnostic Medical Devices Regulation (IVDR) and how does it impact my business?

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It was published in the Official Journal of the EU on May 2017. Gradually replacing the EU’s former directive on in vitro diagnostic medical devices (98/79/EC). The IVDR differs in several important ways from the EU’s previous directive on in vitro diagnostic medical devices. In addition, following the publication of Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, the transition period depends on the class of the IVD device under the current directive and future regulation as well as additional conditions.

What class of products does Biocare Medical provide?

Biocare Medical’s product portfolio spans across three classes as it relates to the IVDR:

Class A – Non-Sterile
Class A non-sterile devices from Biocare Medical include ancillary reagents that include detection systems, wash buffers, chromogens, antigen retrieval solutions, and other reagents that aid the staining process. Antibodies are NOT Class A devices.

Class B – Antibodies
Class B devices from Biocare Medical include antibodies that aid in detection of infectious disease and viruses.

Class C – Antibodies
Class C devices from Biocare Medical include antibodies that aid in detection of cancer.

What Biocare Medical products are Class A products?

Class A non-sterile devices from Biocare Medical include ancillary reagents such as detection, wash buffers, chromogens, antigen retrieval solutions and any other reagents that aid in the staining process including instrumentation. This does not include antibodies. Class A non-sterile devices require an authorized representative. Class A non-sterile device were required to be IVDR compliant beginning on May 26th, 2022.

What Biocare Medical products are Class B and C products?

Class B devices from Biocare Medical include antibodies that aid in detection of infectious disease and viruses. Class C devices from Biocare Medical include antibodies that aid in detection of cancer. Class B and C devices require a notified body. Class B and C devices received an extension to their transition period under IVDR—Class C and B devices on the market prior to May 26th, 2022 will continue to be available for sale until May 26th, 2026 and 2027, respectively (Devices developed after May 26th, 2022 are required to be IVDR compliant upon release).

How do I know if a Biocare Medical product is IVDR Compliant?

If you are unsure if a product maybe sold into the EU under the IVDR (Regulation) or IVDD (Directive) please reach out to your local sales representative, we will be more than happy to assist.

Product Datasheets or IFU’s maybe used to identify if a product is compliant under IVDR and is able to be sold into the EU: this is done by reviewing the datasheets on our website, if the datasheet contains a CE mark it is available to be sold in the EU provided the product has been registered. The CE mark can be found in the footer of the datasheet:

How do I know if a Biocare Medical product class is A, B, or C?

All reagents that are ancillary to an antibody are a Class A – Non-Sterile Device, this includes instrumentation such as ONCORE Pro and intelliPATH. All antibodies that aid in cancer diagnosis are a Class C device and all antibodies that aid in virus or infectious disease detection are a Class B device.

What is an Authorized Representative?

An authorized representative is an organization established within the European Union that has received and accepted a written mandate from a manufacturer, located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks regarding the latter’s obligations under the Regulation. At a minimum, authorized representatives’ obligations include verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.

What is a Notified Body?

A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market certifies the quality systems of their manufacturer. The conformity assessment is a process by which a company demonstrates that the product complies with the requirements set out in the In Vitro Diagnostic Medical Devices Regulation (IVDR). A Notified Body is designated by an EU member state and carries out third-party conformity assessment procedures including calibration, testing, certification, and inspection. There are 7 notified bodies for IVDR in the EU currently and more are being added to meet the demand of the new IVDR regulation each year.

What is a Regulatory Importer?

In order to place a device on the market, importers shall verify the device has been CE marked and that the EU declaration of conformity of the device has been drawn up (Article 13). The manufacturer is identified and that an authorized representative in accordance with Article 11 has been designated by the manufacturer. The device is labelled in accordance with this Regulation and accompanied by the required instructions for use (Annex I, Chapter III) and where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.

Who is Biocare Medical’s Authorized Representative?

Biocare Medical’s Authorized Representative is EMERGO EUROPE (located in Netherlands).

Who is Biocare Medical’s Notified Body?

Biocare Medical’s Notified Body is TÜV SÜD Product Service GmbH (located in Germany).

Who is Biocare Medical’s Importer?

Biocare Medical’s Importer is MedEnvoy Global BV (located in Netherlands).

Why have some products changed from IVD to GLR or GLU?

In some cases, the IVDR regulation’s increased documentation requirements, such as more thorough analytical or clinical performance testing, no longer apply to certain basic products, such as cleaning kits. Accordingly, these products have been relisted from IVDs into General Laboratory Reagents (GLR) or General Laboratory Use (GLU). This change has no impact on the quality that you’ve come to expect from Biocare Medical products, and you will be able to confidently continue selling these re-listed products within the EU.

What can I expect in the future?

You can expect that Biocare Medical will remain committed to quality and to register products under the IVDR. As these products become registered you will be informed through communications like this; informing you of progress, registered products, and any changes that we see coming in the regulatory environment that may impact our business.