What’s new in the MDR and IVDR

The MDR specifies the requirements for medical devices and the IVDR for in vitro diagnostic devices, which must be fulfilled to enable CE marked labelling.

Furthermore, the MDR and the IVDR set out the requirements for medical device manufacturers and other economic operators such as European representatives, distributors and importers.

Examples of medical devices and in vitro diagnostics from the Greiner Bio-One product portfolio:

Medical Devices: Tourniquets, Tube Holder, Blood Collection Sets, Needles, Lancets, etc.

In vitro diagnostics: Blood Collection Tubes, Urine Tubes, Urine Beakers, Urine Transfer Device, etc.

The MDR and IVDR differ in several aspects to the previous directives. The most important changes include:

• Extension of scope
• Designation of a “person responsible for regulatory compliance”
• UDI (Unique Device Identifier)
• More detailed and comprehensive requirements for technical documentation
• Post-market surveillance
• Clinical evaluation
• Requirements for economic operators such as distributors and importers.

The risk-based classification system introduced by the IVDR requires the involvement of a notified body when approving all IVDs, with the exception of Class A IVDs .

EUDAMED is the European database for medical devices developed by the European Commission in order to map the life cycle of medical devices and IVDs.

The MDR and IVDR define the data that must be entered into EUDAMED. Certain parts of EUDAMED are publicly accessible.

The database is not yet fully operational.

Unique Device Identification (UDI) is a system for the identification, labelling and registration of medical devices and in vitro diagnostic medical devices. The aim is to increase patient safety by ensuring complete traceability of products.

The UDI should be applied both with machine-readable identification (e.g. barcode) and in plain text on the product and/or on the packaging. The UDI serves as a key to the UDI database (EUDAMED).

Labelling deadlines in accordance with MDR for Greiner Bio-One products:

Class I: 26 May 2025

Class IIa: 26 May 2023

For reusable products where the UDI carrier must be applied directly on the medical device, the MDR grants two additional years (for Class I – reusable: 26 May 2027)

Labelling deadline according to IVDR for Greiner Bio-One products: Class A: 26 May 2027

The MDR and IVDR apply to all CE marked medical devices and IVDs, regardless of their classification.

The MDR requirements are implemented in stages depending on the classification of the products. The EC certificates issued under the MDD remain valid for the stated term. This was taken into account accordingly in the schedule.

The conformity assessment has already been carried out for Class I medical devices. These already comply with the requirements of the MDR.

For Class Is and IIa medical devices, the EC certificates under the MDD have been extended. These medical devices can therefore be placed on the market under the MDD until the certificates expire.

The requirements of the IVDR are being implemented in accordance with the transition periods defined in the IVDR.

"The European Commission has introduced a proposal to amend the transitional periods for the IVDR, which has since been approved by the European Parliament. The IVDR will continue to enter into force as planned from May 2022, but the transition periods will be adjusted depending on the risk class of the product: For Class A (non-sterile), the transition period will remain unchanged at May 2022, while for Class A (sterile) it will be extended to May 2027. We will take these changes into account accordingly."

With the conformity assessment, manufacturers of medical devices ensure the conformity of the products with the applicable general safety and performance requirements. To this end, the products undergo a corresponding conformity assessment procedure.

Depending on the product classification, it may be necessary to involve a notified body.

“Notified Body” means a conformity assessment body designated in accordance with MDR or IVDR. Depending on the risk class of the products, they carry out tests and assessments as part of the conformity assessment procedure.

All medical devices and in vitro diagnostics for which Greiner Bio-One is the legal manufacturer.

Depending on the planned life cycle, the products are certified according to MDR or IVDR. Greiner Bio-One is complying with the transition periods in accordance with MDR and IVDR.

Yes, all products will be compliant during the transition time.

In the MDR and IVDR, detailed requirements such as post-market surveillance (PMS), clinical evaluation, performance evaluation, vigilance, etc. required. These processes have been adapted accordingly and are part of the quality management system.

Yes, in accordance with Article 15 of the MDR and IVDR, Greiner Bio-One has nominated a Person Responsible for Regulatory Compliance (PRRC).

There are different conformity assessment procedure in the MDR and IVDR. The classification of the medical device / IVD determines which procedure is followed.

For non-sterile class I medical devices and non-sterile class A IVDs a notified body does not need to be involved in the conformity assessment. Therefore, for these devices an EC-Certificate issued by a notified body is not required.

For class Is and IIa medical devices as well as sterile class A IVDs a notified body needs to be involved in the conformity assessment procedure. The notified body issues an EC-Certificate which is referenced in the applicable Declaration of Conformity (DoC) with the corresponding validity date of the EC-Certificate.

A regularly updated list of relevant products is available on request from your local supplier.

Yes, Greiner Bio-One will provide relevant details of the changes on request from your local supplier