Regulation on IVD Medical Devices MDR 746/2017

On 5 April 2017 the EU approved the new Regulation on in vitro diagnostic medical devices, replacing the existing Directive 98/79/EC and Commission Decision 2010/227/EU. The new IVD Regulation has applied since 26 May 2022. With Regulations (EU) 2022/112 and (EU) 2024/1860, the transition periods for existing products have been extended: class D until 31 December 2027, class C until 31 December 2028, classes B and A (sterile) until 31 December 2029.

Key changes:

The IVD Regulation differs significantly from the IVD Directive, including the modified classification rules and the requirements for conformity assessment. The aim is to strengthen the current approval system for In Vitro diagnostic medical devices, making substantial changes to the existing legislation of the IVD Directive (98/79/EC), which was first enacted in 1998.

To this end, it introduces certain improvements, the most important of which are set out below:

• H retention of a Technical File for every In Vitro diagnostic medical devicemanufactured by secondary manufacturers (private label products).
• The introduction of a new categorization system, based on classification ruleswhich, for the first time, take into account the impact on patients. This change affects all manufacturers. The majority of in vitro diagnostic medical devices are currently self-declaration products, but under the new Regulation, approximately 80% of products will require some form of conformity assessment by a Notified Body.
• The extension of the Regulation's scope to other categories of diagnostic products (products for diagnosing predisposition to a condition or disease, products providing information predicting treatment response to medicines, software, etc.).
• Theintroduction on products of a unique device identifier (UDI- Unique Device Identification).

How can manufacturers prepare for the transition?

Manufacturers of in vitro diagnostic medical devices must prepare in good time to ensure that their products comply within the new transition periods.

Attention! There is no longer any differentiation between Primary (OEM) and Secondary Manufacturer (OBL). In the spirit of the new Regulations, the Primary manufacturer is considered a "supplier" of the Secondary, and the Secondary a "customer" of the Primary.

What NOVITAS for you:

The personnel of NOVITAS have extensive experience and expertise in the field of medical devices and related services, and are in a position to support your company with the following:

• Assessment of the completeness of the production technical file of an in vitro diagnostic medical device.
• Revision of an existing production technical file in vitro diagnostic medical device.
• Compilation of the technical file for the production of an in vitro diagnostic medical device.
• Communication with the Notified Body for marking the product with CE.

*Where MD = Medical devices

**Where IVD = In vitro diagnostics