The new in vitro Diagnostic Regulation (EU) 2017/746 (IVDR) which replaces the IVD Directive (98/79/EC), entered into force on May 25th 2017, and will enter into legal application by 26 May 2022 after a 5-yeartransition period.

Team-NB published a consideration paper on November 25, 2020 aiming to identify the key impacts of the IVDR on the current situation of the IVD medical device sector in the EU, and in particular the expanded role of notified bodies regarding IVDR conformity assessment.

While only a minority of in vitro diagnostic devices (20%) are currently under Notified Body oversight, ~85% of devices will require Notified Body assessment prior to CE marking as of May 26, 2022!

Given this situation, and in the context of the current COVID-19 pandemic, Team-NB alerts the European Commission about the difficulties with keeping to the established schedule (as MedTech Europe did before), and requests that the date of application of the IVDR be postponed.

Can we bet on a modification of the current provisions and relax a bit?

The short answer is NO! Even if the Notified Bodies succeed in putting pressure on the European commission, it is difficult to know when we would be informed about a potential postponement. Whatever the outcome, we strongly recommend you to stick to the initial timelines and get ready.

So what are the impacts of the new regulation?

The IVDR has significantly reinforced all of the requirements of the directive and introduced several new requirements as well.

The most significant changes include new classification rules, higher notified body oversight with reinforced conformity assessment procedures, more requirements to establish clinical evidence, and strengthening the notion of monitoring / maintaining performance throughout the life cycle of the system. The regulation also specifies the obligations of each of the economic operators (manufacturers, agents, importers and distributors).

With regards to classification, say goodbye to Annex II of the IVD Directive! With the new regulation, devices are classified according to their risk class, considering individual risk and risk in terms of public health. Based on its intended use, the device will be categorized in class A, B, C or D; D being the highest risk class ands A, the lowest risk class.

Only non-sterile class A devices will not require notify body involvement.

What exactly does this mean?

Conformity assessment by a notified body, usually includes a quality management system (QMS) audit, and, according to the risk class of the various devices, a review of all or a part of the technical documentation, with respect to the general safety and performance requirements.

For Class D devices, the conformity assessment must also include a verification of the compliance of the device by an EU reference laboratory. For class D devices for which no common specification exists, notified bodies will request expert panels (MDCG) to scrutinise their performance evaluation assessment reports.


These provisions raise new challenges for a large number of manufacturers and might significantly impact the time to market.

However, manufacturers and other economic operators are not the only ones to be impacted by the regulation.

Indeed, reinforcement of the role of notified bodies means that they also aure subject to harsher requirements. Out of the 21 notified bodies designated under Directive 98/79/EC (excluding Turkey), only 15 submitted an application to be designated under the new regulation; Only 1 new organization applied.

To date, only 5 notified bodies out of the 16 applicants have been designated, including an English one who is no longer eligible as of December 31, 2020 due to Brexit. 8 joint assessments are still in progress (publication of the European Commission).

The situation is therefore delicate considering that 21 notified bodies are currently in charge of certifying 20% ​​of IVDs under the directive and a maximum of 12 (4 designated and 8 under joint assessment) will have to meet the need for certification of ~ 85% of IVDs under the new Regulation. This is all the more true given that some notified bodies designated under DMDIV regulation are also designated under the DM regulation (EU) 2017/745.

It would therefore be a mistake for manufacturers to focus only on planning the actions necessary to bring their QMS and the technical documentation(s) of their product(s) into conformity.

It is also crucial to identify as quickly as possible a notified body designated with the designation codes applicable for the type(s) of product(s) marketed, and to initiate exchanges to define the possible certification schedule.

Note:  Even if a postponement of the application date is voted, there is a good chance that the problem of overloading of notified bodies will persist. Indeed, they will face the challenge of dealing with the new demand for IVDs and the increased demand for medical devices under the 2 applicable regulations

If you haven’t yet gotten in touch with a notified body, it’s high time to do it !

Big challenges lie ahead, but don’t panic! With a little bit of strategic planning, it’s possible.

Here are a few tips:

  1. Ensure you have correctly identified the risk class of your devices (see Annex VIII and guidance documents MDGC 2020-16 and MDCG 2019-11) and verify that your notified body has been certified for the designation codes applicable for your product(s).
  2. Draw up a conformity and certification schedule based on your internal resources and on the capacity and availability of the selected notified body(ies). Note: you may need more than one notified body if the scope of its designation does not cover all categories of your devices.
  3. Assess the quality of existing data according to the level of risk of your product(s) and corresponding requirements. Check that relevant standards have been used and verify if you have all plans, protocols and reports requested in Annex 1 regarding safety and performance. This review may provide an opportunity for rationalization of the product portfolio and elimination of any marginal products.
  4. Review adequacy of QMS to meet standards and requirements regarding clinical evidence, post-market surveillance and liability for defective devices.
  5. Verify that all your critical suppliers comply with additional requirements defined in IVDR. They may be subject to unannounced inspections by the notified body. Similarly, ensure distributors comply with their specific regulatory obligations.
  6. Contact the UDI issuing entities designated by the Commission (Commission implementing decision (EU) 2019/939 of 6 June 2019) in order to select and implement a UDI system and define basic UDI-DI for each device model (see Annex VI).
  7. Update your technical documentation.

Note: if you already have an IVD on the market, you can use a large part of your existing technical documentation as well as post-market surveillance data to support performance claims and risk management.

  1. Register in the EUDAMED actor registration module (deployed December 1, 2020) and get your Single registration number (SRN)
  2. File your application for conformity assessment with your selected Notified Body and submit your technical documentation according to established schedule. Try to keep the deadlines! There is a long lineup. Delaying the submission date could result in a postponement of the review of your file and scheduled audit(s) to a much later date.
  3. Assign at least one person responsible for regulatory compliance, with the requisite expertise in the field of IVD medical devices and fulfilling minimum qualification conditions (see art.15 & MDCG guidance 2019-7).

So why bet on a possible postponement of the date of application of the IVDR?

Grasp the nettle now  to avoid being in a situation where you will no longer be able to market your products in May 2022.

You are not alone. Nexialist can help you. Contact us !

Writer : Agnès MARTINEC –  DIV Manager