The change journey of the EU medical device directives since 2012 was completed on 5 May 2017 with the publication of EU 2017/745 and EU/2017/746 in the EU official journal. EU 2017/746, which we are accustomed to briefly refer to as IVDR, entered into force on 26 May 2022. However, due to the COVID 19 outbreak from 2020 and delays in the appointment of notified bodies, the transition period until May 2025 has been extended by the EU Commission for existing devices.
The following dates apply for IVD devices of class A sterile, B, C and D for which the conformity assessment procedure in accordance with Directive 98/79/EC (IVDD) does not require the participation of a notified body and a declaration of conformity has been issued in accordance with IVDD before 26 May 2022 will be.
- Class D 26 May 2025
- Class C 26 May 2026
- Class B 26 May 2027
- Sterile A 26 May 2027
If you are designing a new IVD device or planning to make significant changes on a CE-marked device, you must prepare your technical documentation according to IVDR. We recommend that you plan and manage your process in the light of the following information.
IVDR EU 2017/746 CE Marking Process
As with MDR, the CE marking process of a device according to IVDR includes the entire life cycle of the device. The term “life cycle” means “all stages from the initial conception of a medical device to its decommissioning and disposal”. For a correct CE marking, the requirements related to design, manufacturing and QA&RA must be determined starting from the concept design phase. The implementation plans must be made with great care. In other words, you must select the most appropriate conformity assessment procedure allowed by IVDR.
Class A devices and all IVD devices that will be put on the market for the first time after 26 May 2022 must be CE marked according to IVDR . The devices which are already CE Marked before this date can be made available till the dates mentioned above (A sterile, B, C and D class devices) , provided that they are manufactured without any significant change within the framework of Article 110, and certain Quality Management System conditions are complied with IVDR.
The main purpose of the new IVDR is to enable IVD manufacturers to bring safe devices to the market. In this framework, starting from the design phase, a risk management process in line with ISO 14971: 2019 and ISO TR 24971:2020 Annex H shall be implemented. Performance evaluation shall be done in accordance with the legislation for targeted analyte. Possible clinical hazards for patients and users shall be minimized as much as possible, and a positive risk benefit analysis result shall be proven for the overall performance of the device. As an IVD manufacturer, by following the basic steps listed below you can create a solid technical documentation for IVDR compliance.
Step 1 – Define Intended Purpose
It is very important that you accurately describe the intended purpose of your IVD device. The GHTF guidance document (GHTF / SG1 / N70: 2011) defines the intended purpose as follows;
” The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer.”
After defining the intended purpose of your device, it is necessary to make sure that it falls within the definition given in Article 2 of IVDR EU 2017/746. As clearly stated in Article 2, specimen receptacles are also treated as IVD devices.
Step 2 –Determine the risk classification according to Annex VIII
7 rules for classification are listed in Annex VIII of the new EU Medical Device Regulation. There are 4 risk classes in total (A,B,C,D). These are generally determined according to the criticality and risks that the targeted analyte and measurement result may create. You must define the risk classification of your device according to one of the 7 rules, taking into account the intended purpose. Incorrect definition of the risk classification can lead to a wrong conformity assessment procedure. Therefore, correct classification is one of the most important steps throughout your certification process. For convenience, you can also use the examples in the guide document MDCG 2020-16 rev.2.
If more than one rule applies to your device, you must consider the highest risk classification.
Step 3 – Choose the conformity assessment procedure
As explained in the step above, correct classification plays a critical role in the certification process IVDR EU 2017/746 . Article 48 defines conformity assessment procedures according to risk classification with reference to the relevant annex of the regulation. (Annex IX, X, XI or combinations) The manufacturer must correctly apply the procedure defined in the relevant annex to CE mark its IVD Device in accordance with the regulation.
Step 4- Implement an effective QMS
The safety of the IVD device does not depend only on the design. All product realization processes within the device lifecycle, such as purchasing, incoming quality control, manufacturing, process control and final inspection, play an important role in safety. Therefore, an effective Quality Management System (QMS) is required so that your device can be CE marked safely.
You can choose ISO 13485:2016 to meet the QMS requirements given in your conformity assessment procedure (eg Annex IX).
Step 5 – Design a safe device (Performance Evaluation)
The design of the device shall ensure its intended purpose and safety.Hence, you must comply with harmonized standards and, if any, “common specifications” related to your product.
For a safe design, the design procedure shall include effective planning and review, verification and validation, as defined in ISO 13485:2016 or any similar quality management system standard. Therefore, the functional, performance, usability and safety requirements shall be determined in parallel with the relevant harmonized standards and common specifications, if available. These inputs shall be verified and validated at appropriate stages and translated into design outputs. In addition, it would be very helpful if you could create a traceability matrix to demonstrate your medical device’s compliance with the General Safety and Performance Requirements (GSPR) in Annex I to IVDR EU 2017/746.
Step 6- Prepare technical documentation
Technical documentation is one of the essentials for CE Marking. In accordance with IVDR Annex II requirements, as required by the selected conformity assessment procedure, you must create your technical documentation and submit to your notified body if applicable. (Not required for Class A devices)
Using an auditable structure that includes Annex II headings as a format will provide significant benefits, especially in presentation to the notified body or, when necessary, to the legal authorities. With all your technical information and reports in this file, you must prove that your device is safe and meets the current requirements of the regulation. Performance evaluation according to Annex XIII or Annex XIV is extremely important . The MDCG and IMDRF guidance documents can be used as an effective tool to comply with the requirements of both annexes.
Keep in mind that the technical file must be a “controlled document” and must be updated throughout the lifecycle of your device in line with design, manufacturing, regulatory or other applicable changes.
Step 7 – Contact Notified Body
For IVD devices classified as A sterile, B, C,D, the notified body shall be involved in the CE marking process. Nonsterile Class A devices can be placed on the market with a valid declaration of conformity to be issued after the completion of the technical dossier and the relevant QMS requirements. For devices other than Class A, in most cases the conformity assessment procedure chosen requires an on-site QMS audit. The technical file review time depends on the workload of the selected notified body complexity of the IVD device.
Step 8 – Market Surveillance
After CE marking, the IVD device can be put on the market. IVDR requires to collect data by applicable methods to identify potential hazards related to design and production processes during use. It is necessary to prepare reports such as PMS, PSUR according to the requirements of the device class.
To ensure the safety of your IVD device throughout its lifetime, effective procedures shall be established and implemented for these topics. The data obtained from the PMS process shall be evaluated and necessary corrective actions shall be planned and implemented.