In Vitro Diagnostics (IVD): Documentation and Approval

In vitro diagnostics (IVD) are medical devices that are regulated in their own regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)) due to their special nature:

The definition of in vitro diagnostics is laid down precisely in the IVDR, Art. 2. (2):
"In vitro diagnostic medical device means a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software, or system, individually or in combination, intended by the manufacturer to be used for the in vitro examination of specimens, including blood and tissue donations, derived from the human body, exclusively or principally to provide information on one or more of the following..."

Safe and reliable products should result from the efficient interaction of the various IVD quality management processes. Safety and performance of the products must be monitored and confirmed throughout the entire product life cycle. In the technical documentation, manufacturers provide proof to third parties that these processes are carried out correctly and in compliance with the respective target country.

We help you meet your regulatory requirements at all levels and at any point in the product lifecycle.

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New Transition Period?

With the proposed amendment to Regulation 2017/746 dated January 23, 2024, the EU Commission wants to give manufacturers more time to transition to Regulation 2017/746 under certain conditions. Stay on top of all the changes.

Do you have any questions? We look forward to contributing to your team's success.

Our Services at a Glance

In Vitro Diagnostics Regulation (IVDR): What Applies Today?

There were 5 years between the entry into effect of the IVDR 2017 and the start of validity in 2022. The first IVDR certificates have been issued, but this is not yet the case for the most in vitro diagnostic devices!

There was and still is a lot to do. At the beginning of 2022, the IVDR transition timeline for most product classes was extended, but the start date of the IVDR was not postponed. Since 05/26/2022, some requirements of the IVDR must already be met for all product classes. These include:
  • post-market surveillance,
  • market surveillance (by the relevant authorities),
  • vigilance and
  • registration of economic operators and of products.

IVDs may continue to be placed on the market or put into service if they continue to comply with Directive 98/79/EC as of the date of application of the new IVD Regulation and if there are no significant changes in the design and intended purpose of these devices. As of May 2022, IVDD certificates may no longer be issued.
  • There is no extended deadline for class A non-sterile devices! These should be IVDR compliant since 05/26/2022 (self-declared).
  • There is no IVDR transition timeline for new developments; here it is necessary to fulfill all requirements of the IVDR!

Amendment Proposal for 2017/745 & 2017/746: Another Extension of the Transition Period?

For more than 80 % of in vitro diagnostic devices under IVDD, manufacturers could previously declare conformity themselves, without the involvement of a Notified Body. Under the new classification rules of the IVD Regulation, approximately 80 % of devices fall into Class B, C or D and therefore must be certified by a Notified Body.

The shortage of Notified Bodies (there are very few Notified Bodies so far in addition to the higher overall workload) has not been solved yet. To what extent the new transition periods will be sufficient to solve both this backlog and your resource shortage is still in question.

In order to ensure the availability of in vitro diagnostics for patient care, in particular the provision of "high-risk products", the EU Commission wants to grant manufacturers more time for the transition to Regulation 2017/746 on in vitro diagnostics (IVDR) under certain conditions.

Technical Documentation for In Vitro Diagnostics

The technical documentation must be revised and adapted in the entire context of the IVDR for all existing products. Risk management results influence the performance evaluation and usability of your IVD and vice versa. The purpose, requirements, specifications, verification/validation, and labeling must be coordinated. Traceability is therefore required from the product idea to the finished product.

Post-market surveillance (PMS) requirements also need to be implemented. Depending on the risk class, different reports are required: PMS reports for class A & B or the Periodic Safety Update Report (PSUR) for class C & D. Not to be forgotten: a summary report on safety and performance (Summary of Safety and Performance, SSP) for Class C & D products is also required.

Information on the content of the required reports, which are always preceded by a plan, can be found in the IVDR and in specific guidelines from the MDCG (Medical Device Coordination Group).

How Much Time Does IVDR Adaptation Cost? A Realistic Calculation Including an Example

From our discussion with manufacturers, we know that 200 working hours are often calculated for the revision of a single product file. So far, so good: That means a pure, dedicated working time of about 5 weeks for a full-time employee. Why "pure" working time? Because this calculation would require the following:
  • The full-time employee has been trained;
  • a project plan for the exact procedure should be ready;
  • the full-time employee knows exactly how to implement the requirements;
  • there are no other tasks for your regulatory affairs employees within these 5 weeks;
  • cooperation between departments is smooth and without incident.

Is this scenario actually realistic? Our experience shows that this rarely works. In your planning, you should also consider that your quality management processes will also have to be revised and new templates should be created.

Need support? We look forward to contributing to your team's success.

We Support You With These Services

Creation and maintenance of the technical documentation:
  • checking the technical documentation of in-vitro diagnostics already on the market, i.e. "legacy devices" and "old devices" against the regulatory requirements,
  • creation of the content of the technical documentation (EU and international) - in compliance with standards, laws, and regulations for existing products and also in the context of new developments,
  • communication with Notified Bodies, authorities, and test laboratories for analytical and/or clinical studies,
  • review/adjustment of the implementation of IVDR requirements based on the new MDCG guidelines.
  • We also support you in the area of clinical affairs in the approval process for your clinical studies: e.g. applications to the ethics committee and the higher federal authority (BOB).

Revision and adjustment of the quality management system:
  • analysis of the need for changes,
  • adjustment of processes,
  • assistance with audits.

Other services:
  • software development process according to IEC 62304,
  • performance evaluation for software products,
  • support for the documentation and the QMS for in-house in-vitro diagnostics.
We work with various laboratories and are happy to support you in your search for a suitable laboratory or suppliers of human samples, such as sera or plasma.

If you need any external support for analytical and clinical data collection:

Please contact us!

Your Benefits When Working With Us

  • We are your reliable partner for adapting your QM processes and developing and revising the technical documentation of your IVD.
  • You will receive all documents for your technical documentation ready for signature on your templates for approval (international) or product certification (EU). We would also be happy to provide you with templates and advise you on choosing the right format for your technical documentation (IMDRF, STED).

  • Our 20 years of experience in the documentation, the certification process, and also in the verification and validation of IVDs ensure that we achieve your goals quickly and efficiently.
  • Our GAP analyses provide recommendations for action at all levels of your regulatory activities (QM system, technical documentation, product portfolio).


Everything Planned Already?

The new classification rules and the resulting increase in regulation via the Notified Body confront manufacturers with tremendous challenges. In view of the time constraints, you need a solid and elaborate plan how to revise the technical documentation.

Contact us to benefit from our expertise.