IVDR Notified Body Certification Services – Sertio, a Kiwa company
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This service is intended for manufacturers of in vitro diagnostic medical devices (IVDs) seeking to place their products on the EU market. It is relevant for companies of all sizes, including established manufacturers, start-ups, and organizations transitioning legacy devices from IVDD to IVDR compliance.
What is it and what it includes?
Sertio, a Kiwa company, as a designated Notified Body under EU Regulation 2017/746 (IVDR), conducts independent conformity assessments for IVD devices. The service covers the full certification process for all device classes (A sterile, B, C, D), including technical documentation review, performance evaluation assessment, quality management system (QMS) assessment, and where applicable; engagement of European Reference Laboratories or Europen Medicines Agency consultation.
Benefits of the service
- Enables legal placement of IVD devices on the EU/EEA market.
- Supports timely transition from IVDD to IVDR for legacy devices.
- Provides impartial, expert assessment by Notified Body.
- Reduces regulatory risk and enhances market confidence.
- Offers global service reach from a Finland-based, internationally recognized body.
Why choose Sertio, a Kiwa company?
Sertio, a Kiwa company, is a trusted Notified Body with extensive experience in IVD conformity assessment. As part of the Kiwa Group, Sertio combines IVD expertise with global reach, ensuring impartiality, objectivity, and up-to-date knowledge of EU regulations. The team is accredited for ISO 13485 certification and is committed to transparent communication, timely service, and supporting clients through every step of the IVDR certification process.
Steps in conformity of the assessment process
Device classification & application
Manufacturer classifies the device and submits an application to Sertio, a Kiwa company.
Contract establishment
A contract is signed within the required regulatory deadlines.
Technical documentation review
Sertio, a Kiwa company, reviews the device’s technical file and supporting evidence.
QMS assessment
Evaluation of the manufacturer’s quality management system for IVDR compliance.
Conformity assessment & CE marking
Upon successful review, Sertio, a Kiwa company, issues EU QMS certificate / EU TDA certificate / EU QA certificate, enabling CE marking and EU market access.
Ongoing surveillance
Regular audits and post-market surveillance to maintain certification validity.
Applicable Norms or Regulations
- EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- ISO 13485 – Quality management systems for medical devices
Frequently Asked Questions
Who needs IVDR Notified Body certification?
Manufacturers of IVD devices (Classes A sterile, B, C, D) intending to place their products in the EU market require Notified Body certification under IVDR.
What is the deadline for IVDR compliance?
All manufacturers must have an IVDR-compliant QMS by 26 May 2025. Transitional deadlines vary by device class; timely application and contract with a Notified Body are essential.
What does the conformity assessment process involve?
It includes device classification, technical documentation review, QMS assessment, and ongoing surveillance to ensure continued compliance.
Can legacy devices remain on the market?
Legacy devices can utilize transitional provisions if applications and contracts are completed by the specified deadlines. After these, only IVDR-compliant devices may be placed on the market.
Is Sertio, a Kiwa company, the same as Kiwa?
Sertio is part of the Kiwa Group but operates independently as a Notified Body for IVDR certification.
CE Marking of Medical Devices in accordance with MDR
Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.
ISO 13485 Medical Devices
ISO 13485 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.
CE marking of Medical Devices in accordance with the MDD
Kiwa Notified Bodies are able to provide all the necessary services to obtain comprehensive answers and reliable information on the Medical Device certification process in accordance with Directive 93/42/EEC. Thanks to the experience of Kiwa Notified Bodies, companies of the medical sector can demonstrate compliance with the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. Moreover, thanks to the technical expertise of Kiwa Medical, medical device manufacturers can rely on a trusted partner, able to guarantee the execution of an effective conformity assessment process, which can combine the guarantee of market safeguarding with the business tool.
