The IVDR: One year after its entry into force

The IVDR 2017/746 regulation for in vitro diagnostic medical devices has been in force for a few years and with the start of validity on 26 May 2022, the time has now come for a first stocktaking. As a result of the changes, some in vitro diagnostic medical devices must be classified in higher levels and certified for the first time with the involvement of a Notified Body. However, since some questions remained unanswered shortly before the entry into force, the transitional periods were adjusted to relieve the manufacturers in this point. Now another change is about to be released: the sell-off deadlines will no longer apply.

Major changes brought about by the IVDR

Not only does Regulation (EU) 2017/745 on medical devices (MDR) bring some innovations for manufacturers, but Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is also included in this series, which caused a lot of commotion at the beginning. However, the extension of the transition periods with simultaneous staggering according to device class , has eased the situation somewhat. In general, the scope of the IVDR is broader than that of the previous Directive 98/79/EC. This also implies new and higher requirements for manufacturers and other actors. The main changes include the following aspects:

• New classification system: The new risk-based system is focused on patient safety and is based on four classes A, B, C and D. Devices belonging to class A have a low risk and devices belonging to class D have the highest risk. Class A devices are considered to be low risk and class D devices are considered to be the highest risk. At the same time, it was determined that a Notified Body must be involved for devices of class B and higher.
• More stringent conformity assessment procedures: With the IVDR, the implementation of conformity assessment procedures is in principle limited to three possibilities. The basis for this is either the technical documentation, the complete quality assurance system or a type examination.
• Increased requirements overall: This applies especially to the QM system, the technical documentation and the post-market surveillance system.
• Person Responsible for Regulatory Compliance: Article 15 requires manufacturers to appoint a responsible person to ensure that all necessary regulatory requirements are met and monitored.
• Obligations in labelling: The introduction of the UDI (Unique Device Identification) and its requirements help to improve the traceability of devices.
• EUDAMED database: The newly introduced database obliges manufacturers and other actors, also of medical devices, to deposit data about the company and the devices in it. This will become important once the database is fully available (as of February 2023).

Deletion of the sell-off period

Due to the much-noticed proposal of the Commission in December 2022 to equalize the deadlines of the MDR (EU) 2017/745, changes to the IVDR (EU) 2017/746 have also been initiated again. The amending regulation has not yet been officially published in the Official Journal of the European Union. However, the following changes are already foreseeable:

There will no longer be sell-off deadlines for compliant devices. All in vitro diagnostics that have been placed on the market according to IVDD until May 26, 2022, as well as all devices that may still be placed on the market according to 98/79/EC according to the applicable dates, can be sold without any time limit. But: of course the device life cycle / shelf life defined by the manufacturer has to be considered.

Directive 98/79/EC continues to apply to the devices covered by it and no longer “only” until May 26, 2028.

According to Article 110 (3), the relevant dates for placing devices on the market in conformity are as follows

• May 26, 2025 for devices that already required the involvement of a Notified Body under the IVDD.
• For devices that are reclassified by the IVDR and now require the involvement of a Notified Body for the first time
  • 05/26/2025 – Class D
  • 05/26/2026 – Class C
  • 05/26/2027 – Class B
  • 05/26/2027 – Sterile Class A

Until these deadlines, devices can be placed on the market with a declaration of conformity according to 98/79/EC. However, the declaration of conformity must have been issued before 26.05.2022 and there must be no significant changes to the design and intended purpose of the medical devices by the end of the transition period – please also refer to MDCG Guidance 2022-6.

Conformity assessment: the way to the right procedure

When the IVDR was announced, many manufacturers naturally already started thinking about how the changed requirements for the devices could be implemented and what steps had to be taken to achieve this. The conformity assessment procedure in particular plays a central role here.

For class A devices, the so-called declaration of conformity applies. Here, the conformity assessment procedure is the responsibility of the manufacturer and is evidenced by the complete technical documentation of the device and the post-market surveillance (Annex II and III). For class B, C and D devices, the involvement of a Notified Body is required. The conformity assessment procedure can be carried out in different ways. The assessment of the entire technical documentation forms the basis in each case and, depending on the exact device classification, is supplemented by the examination of the QM system (Annex IX), the examination of the deviceion quality assurance (Annex XI) or a type examination (Annex X).

Table 1 Simplified representation of the possible conformity assessment procedures according to IVDR

Role of economic actors and authorities

Other economic operators, such as distributors, must now also be aware of their changed obligations and will be held jointly responsible. These are similar to the requirements for distributors under the MDR.

Guided by the manufacturers, distributors, among others, must now also pay special attention to post-market surveillance. Information on incidents and complaints must be collected and forwarded to the manufacturer. The obligations thus extend over the entire device life cycle. Furthermore, the validity of the certificates and the associated transitional periods also cause uncertainty. The rule is that distributors may make IVDs available on the market through their usual channels if the devices were purchased from the manufacturer before the respective deadline and were thus already placed on the market.

The authorities are not exempt from extended obligations either. Due to the new classification rules, a much larger number of in vitro diagnostic medical devices must be supervised and monitored by a Notified Body in the future. Currently, however, only 8 bodies have been designated, which does not alleviate the situation significantly. Among other things, this bottleneck had also led to an adjustment of the transition periods, which has brought about a certain relief for many manufacturers. But unfortunately there is a lack of further notified bodies so far, including those that were still notified under the IVDD and whose customers are now waiting impatiently.

However, when implementing the IVDR and all its requirements, it should not be forgotten that there are also other generally applicable directives and regulations that should by no means be disregarded and may also have to be implemented. This is because both the old directives and the now valid MDR and IVDR regulations function according to the principle of the “New Approach”, a generally valid concept of the EU. These supplements can address essential points such as the declaration of conformity or explain questions about the framework conditions – the “Blue Guide” is a good helper here.

Support in the implementation process as an IVD manufacturer

Although individual transition periods still seem far away – they are coming faster than you think. For class A devices they have already passed. Well, have you already started implementing the IVDR in your company? Are you in the middle of the conformity assessment process and unanswered questions have arisen? Do not hesitate and contact us! We will advise you specifically according to your individual situation and support you throughout the entire process.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.