In vitro diagnostic medical devices (IVDs), used for a wide range of diagnostic assays, have a significant impact on peoples’ treatment. With tens of thousands of IVDs currently on the market, ensuring their safety for use in health care settings, laboratories or at home is paramount.

More than 70% of treatment decisions are based on laboratory tests, according to estimates. This underlines the importance of ensuring IVD safety and efficacy.

There are many types of IVD for different diagnostic purposes:

Reagent kits
Test strips
Diagnostic laboratory devices
Software

To ensure safe IVD and patient safety products marketed in the EU must comply with Regulation IVDR (EU) 2017/746 which came in effect on May 26, 2022). This Regulation includes not only quality system requirements, but also detailed requirements for the design, safety and performance of devices.

On this page you will find information on the requirements and legislation applicable to IVDs in Europe and the services SGS Fimko can provide as an IVDR notified body.

Conformity assessment by a notified body

According to the IVDR, IVD medical devices are classified into risk categories A, B, C and D, based on their intended use and clinical risks. Those IVDs belonging to risk categories A sterile, B, C and D require a notified body for conformity assessment before they can be placed and sold on the EU market.

SGS Fimko Oy (SGS) is a notified body (0598) designated under the IVDR. For each IVD medical device, the qualification required for the assessment is defined according to the assessment procedure. Check our defined scope as an IVDR notified body in the NANDO database. We carry out all assessments in a professional and impartial manner. To find out more, read our declaration of impartiality.

And IVD’s risk category dictates the procedures to be followed for IVDR certification. MedTech Europe has produced a clear chart to refer to when considering the appropriate assessment procedure (IVDR Article 48).

SGS’s IVDR certification process

As notified body 0598, are permitted to certify all IVDs within our area of competence.

The certification process starts with the review of the application and involves several critical steps. Our brochure ‘Your Certification Process Explained’ provides a summary of the process requirements and what the process entails.

Additionally, we offer services to economic operators who fall under Article 16 of the IVDR Regulation – such as importers and distributors who relabel and/or repackage IVDs. Our brochure ‘Your IVDR Certification Process Explained – Article 16’ describes the steps of the assessment process required by Article 16.

If you wish to place an IVD medical device on the EU market and require a notified body certificate of conformity, please contact us by completing the IVD questionnaire. You can complete and submit this form on our website or return the completed form by email. Please contact us in the first instance by completing our contact form.

Due to the unique technological characteristics of IVD medical devices, each IVD medical device certification process is unique. Consequently, each device is subject to an application review in accordance with the IVDR Regulation, after which we can provide an estimate of the cost and likely timeline for certification. Find out more about our costs.

Technician Carrying out Scientific Research in a Laboratory

Structured Dialogue with SGS Fimko

What structured dialogue is ─ and what it is not?

MDCG 2022-14 and MDCG 2019-6 rev. 5 encourage Notified Bodies and manufacturers to organize structured dialogues. A structured dialogue is a structured communication between a Notified Body and a manufacturer prior to, during and after the conformity assessment process. Its goal is to clarify expectations, ensure completeness of submissions and improve efficiency without crossing into consultation. A structured dialogue helps identify gaps early and fosters mutual understanding, while maintaining the Notified Body’s impartiality.

The focus of a structured dialogue should be on what needs to be fulfilled, not how to fulfill it. Manufacturer’s questions should respect the Notified Body’s independence, objectivity and impartiality requirements and should not lead to consultancy. The responsibility to meet the regulatory requirements remains with the manufacturer. A structured dialogue is not a formal conformity assessment and does not replace any official review nor affect any future certification decisions.

See our brochure Structured Dialogue with SGS Fimko to familiarize yourself with our structured dialogue process and typical topics.

How to request a Structured Dialogue with SGS Fimko?

If you want to initiate a structured dialogue and you are an existing client, please contact your designated contact person at SGS Fimko, who will assist you further.

If you are a new client, please contact us via this contact form or by email: IVD.devices.fimko@sgs.com, and our expert will get back to you.

Further information

The legal text of IVDR (EU) 2017/746 is further clarified by the MDCG guidelines published by the Medical Devices Coordination Group, which manufacturers also should refer to. Although the MDCG guidelines are not a legal text as such, the procedures mentioned therein are widely applied in the conformity assessment of IVDs and serve as guidance for both notified bodies and manufacturers. They contain practical guidance on a wide range of topics, such as EUDAMED, the definition of significant changes and performance evaluation.

The Notified Body community, Team-NB, publishes valuable guidance on its document pages. In particular, the Team-NB Position Paper BPG for Technical Documentation Submission and the IVDR Certification Process are highly recommended. In addition, the following guidelines are recommended, as applicable: