- As per EU IVDR, the devices are classified A, B, C and D, based on the intended purpose and inherent risks. The conformity assessment route and post-market requirements mainly depend on the classification of the device. The classification of a particular device is carried out as per Annex VIII of EU IVDR.
- For Class A devices, the manufacturer can declare conformity by issuing the EU declaration of conformity after making the technical file as per EU IVDR. For Class B, C and D devices, the conformity assessment will be done by notified bodies.
- Class D consists of high-risk devices and covers the blood grouping devices; the examples are the devices intended for Hepatitis B, C and D, HIV 1 and 2, ABO System, Rhesus. Class C covers a mix of devices, such as companion diagnostics, some self-testing IVDs and devices, which have less risk to the wider population.
- Class B covers a greater number of devices with less risk than Class C & D. Self-testing devices for pregnancy and fertility testing, devices intended for detection of Influenza A/B virus, which is a non-pandemic, are some of the examples for Class B devices.
EU IVDR Regulation for CE Marking
EU IVDR Regulation – It is important to understand the difference between a medical device and an in-vitro diagnostic medical device (IVD). IVDs are generally not in direct contact with the human body and do not have any therapeutic effect compared with a medical device. IVDs are basically reagents, reagent products, instruments, software or system and systems, as intended by the manufacturer, used to diagnose a disease or other conditions.
- EU IVDR CE Marking means that the particular IVD meets the European regulations, and it is permutable to market in the European Union. At present, the IVD Directive 98/79/EC is0 applicable, and from 26 May 2022 onwards, EU IVDR 2017/746 shall apply.
- The devices categorized as IVD require CE marking as per the IVD Directive 98/79/EC. The involvement of Notified Bodies limited to the devices listed in Annex II of the directive. Most of the devices, at present, are supplying to Europe based on the self-declaration of the manufacturer.
- The manufacturer must ensure that the IVD meets the Essential Requirements of Annex I of IVDD. There must be technical documentation for IVD, irrespective of classification, which demonstrates compliance with applied harmonized standards and applicable Essential Requirements as per IVDD.
New EU IVDR Regulation (IVDR 2017/746)
- The new legislation of EU, the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 came into effect in May 2017 and shall apply from 26 May 2022 onwards by replacing the IVDD 98/79/EC. The IVDR comes with an extension of scope in different aspects compared to the present IVDD.
- As per EU IVDR, the IVDs are classified under four different classes, A, B, C and D, based on the risk associated with the device. As per this new classification, more than 80% of IVDs will require CE certification with the involvement of Notified Bodies.
- The IVDR comes with many requirements to ensure that the IVDs marketed in the EU must meet compliance with all aspects. It provides guidelines to economic operators, comes with a specific structure for technical file, the appointment of PRRC, and most importantly, the UDI.
EU IVDR CE Marking Consultants
- At present, nearly 20 % of IVDs requires Notified Body involvement as per IVDD; however, once EU IVDR comes into action, more than 80% of IVDs will require Notified Body scrutiny to get the CE mark. It means the manufacturers have to upgrade their files as per EU IVDR requirements.
- Preparation of PE plan, PMPF If the manufacturer does not have a team of experienced QMS & RA professionals, then EU IVDR transition is exceedingly difficult for them. They must hire experts or consultants who are having good experience in this field.
- IVDR Consultants or experts can support the organization by doing the gap analysis, which includes the classification of the device as per EU IVDR, review of technical data, provide guidance and make strategies to meet the requirements and also supports all the way to get the CE mark by communicating with Notified Body in every aspect.
Additional Information about new EU IVDR 2017/745
Our Services
Quick Contact
We will respond to you within one working day.