Your partner for the market launch of in-vitro diagnostics
At MEDAGENT, we understand the challenges that the IVDR (In Vitro Diagnostic Regulation) poses for manufacturers and distributors of in-vitro diagnostics. Our team of experts ensures that you can easily and reliably meet all the requirements of the IVDR.
FAST
We accelerate your market approval through efficient processes and comprehensive expertise.
Safe
Our precise knowledge of regulatory requirements minimizes errors and risks.
Economical
Precise planning helps to avoid unnecessary costs and leads to financial savings.
Clever
Benefit from our network and access to the latest regulatory information.
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MEDAGENT - your strategic partner for quality management, regulatory requirements, process and software validation and quality testing in the field of medical devices.
With our offices in Germany, the USA, Brazil and the UK, we offer you a highly qualified team and the specialist expertise you need to operate successfully in international target markets. We accompany you with commitment and expertise from the initial idea through to the successful market launch of your products and provide you with advice and support throughout the entire product life cycle - for smooth, compliant and sustainable market positioning.
Our services

Implementation of QM systems
We support you in adapting or introducing your quality management system in accordance with the IVDR requirements.

Classification of IVD products & software
We help you with the correct classification of your products in lists A, B, C and the respective conformity assessment procedures.

Technical documentation
Our experts will support you in preparing the technical documentation in accordance with Annex II and III of the IVDR.

Process validation
We guide you through the DQ, IQ, OQ and PQ qualification phases for seamless validation.

Unique Device Identification (UDI)
We implement the UDI requirements for your IVD products and provide support with EUDAMED registration.

CE conformity
We guide you safely through the conformity assessment procedure for CE marking.

Risk management
Development of a robust risk management strategy in accordance with ISO 14971 and implementation of effective postmarket surveillance.
What are in-vitro diagnostics?
In vitro diagnostics (IVDs) are medical devices such as instruments, devices and reagent products that are used to examine samples from the human body in order to obtain information about the patient's state of health.
With the entry into force of EU Regulation 2017/746 (IVDR) on May 26, 2017, the requirements for in-vitro diagnostics (IVD) were fundamentally revised and replaced the previous IVDD. Since then, manufacturers of IVD products who place them on the market in the European Union (EU) are obliged to comply with the provisions of the IVDR Regulation. This regulation affects not only manufacturers, but also notified bodies, importers, distributors and laboratories that act as manufacturers of in-house IVD products, clinics as operators and suppliers of laboratory products "For Research Use Only" (RUO) and pharmaceutical companies.
The IVDR Regulation places high demands on manufacturers and distributors of IVD products and includes numerous complex and far-reaching requirements. MEDAGENT is your reliable partner to guide you through this demanding process. With our expertise in the approval and certification of IVD products, we help you to meet the IVDR requirements efficiently and reliably - with minimal use of resources. Rely on MEDAGENT to successfully bring your IVD products to market in accordance with the IVDR regulation.
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has significantly tightened the regulatory requirements for IVDs. This means for manufacturers:
- Introduction of a risk-based classification system
- Stricter conformity assessment procedures
- Detailed specifications for the technical documentation
- Mandatory Unique Device Identification (UDI)
- Increased involvement of notified bodies
- Need for reclassification and recertification of existing products
- Adaptation of the quality management system
- Extended requirements for labeling and risk management
- Comprehensive post-market surveillance
- Specific regulations for software and in-house devices
The IVDR (Regulation (EU) 2017/746) regulates the entire in-vitro diagnostics (IVD) market in the European Union and is aimed at manufacturers, distributors, importers, laboratories, users, notified bodies and national authorities. In the "General safety and performance requirements", the IVDR precisely defines the requirements that in vitro diagnostic medical devices must fulfill in order to ensure the safety, performance and reliability of the products. These requirements apply to all phases of the life cycle of an IVD, from development and approval through to market surveillance.
Manufacturers of medical devices in particular are confronted by the IVDR with extensive requirements that affect both the manufacturer itself and the IVD product. The central requirements include
Quality management and documentation:
Implementation of a comprehensive QM system: A robust quality management system (QMS) must be implemented to ensure continuous compliance with IVDR requirements and to guarantee the quality of products throughout their life cycle.
Detailed technical documentation in accordance with Annex II and III: For each IVD product, detailed technical documentation is required that includes all relevant information to demonstrate the safety and performance of the product. This includes product design, clinical data and risk analysis.
Appointment of a responsible person for regulatory compliance: A qualified responsible person must be appointed to ensure that all regulatory requirements are met in accordance with the IVDR. This person is responsible for ensuring proper compliance and regularly updating the technical documentation.
Manufacturers of in-vitro diagnostics (IVD) are obliged to introduce a quality management system (QMS) that is effective not only in the development and production, but also in the market surveillance of the products. With the exception of class A products, certification of the QMS is generally required.
In addition to the QMS, the IVDR (In Vitro Diagnostic Medical Devices Regulation) also requires the implementation of a risk management system that ensures that a positive balance is struck between the benefits and risks of the product throughout its entire life cycle.
In order to ensure regulatory compliance in accordance with the IVDR and to ensure that the technical documentation is prepared in accordance with the manufacturer's own quality management system, manufacturers must also appoint a person responsible for regulatory compliance. This person is responsible for ensuring proper compliance with regulatory requirements and the continuous monitoring of compliance.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) sets out product-specific requirements that provide for a risk classification for each IVD product and software IVD. Manufacturers must determine the appropriate risk class for each product in order to meet the requirements of the regulation.
The technical documentation of an IVD must comply with the essential safety and performance requirements set out in Annex I of the IVDR and meet the requirements of Annex II of the IVDR. To demonstrate compliance with these requirements, manufacturers must apply harmonized standards and, where applicable, the Common Specifications.
Continuous performance evaluation is required to ensure the safety, performance and benefit of the IVD. If clinical data are insufficient, an additional performance study must be conducted.
Another important point of the IVDR is the unique identification of the product by means of "Unique Device Identification" (UDI), which results in the registration of the product in the European database for medical devices (EUDAMED). Furthermore, the IVDR places requirements on instructions for use, accompanying materials and labeling (imprints and packaging).
Depending on the risk class of the product, manufacturers undergo a conformity assessment procedure. For products in risk classes B, C and D, the involvement of a notified body is required in order to obtain the CE mark and draw up a declaration of conformity. Products in risk class A are exempt from this.
In addition, the IVDR obliges manufacturers of IVDs to monitor the entire life cycle of their products on the market. This includes the collection of data as part of post-market surveillance and vigilance in order to identify potential risks at an early stage and take the necessary measures. If risks are identified, the authorities must be informed immediately.
As outlined above, the IVDR places extensive requirements not only on manufacturers of IVDs, but also on other players in the market, including importers, distributors, hospitals and operators, laboratories acting as manufacturers of in-house IVD products, as well as suppliers of "For Research Use Only" (RUO) products and pharmaceutical manufacturers. All of these players must ensure that they meet the requirements of the regulation in order to guarantee the safety and performance of IVD products on the market.
The IVDR Regulation introduces significant innovations and differs from the previous IVDD Directive in key respects:
The scope of the IVDR Regulation has been significantly expanded compared to the IVDD. It now also includes high-risk products that are used exclusively in a single healthcare facility, as well as in vitro diagnostic medical devices that provide diagnostic services - including internet-based services, genetic testing and other tests that indicate a patient's predisposition to certain diseases or the effect of treatments.
The IVDR introduces a new classification system based on the risk rules of the Global Harmonization Task Force (GHTF). This system distinguishes between risk classes A to D, with class A representing products with a low risk and class D products with the highest risk. Classification is carried out in accordance with the rules for the correct classification of IVD products.
According to the IVDR, manufacturers of in vitro diagnostic medical devices must designate a qualified person who is demonstrably responsible for compliance with the regulatory requirements within their organization.
The IVDR also extends the role of notified bodies. In many cases, the new risk-based classification system requires the involvement of a notified body in the approval of IVD products, which significantly increases the number of products to be tested (with the exception of class A products). The requirements for the designation and monitoring of notified bodies have also been significantly tightened, as competent authorities and reference laboratories must now be involved in the conformity assessment of high-risk devices. These changes are likely to lead to longer conformity assessment procedures.
The introduction of Unique Device Identification (UDI) facilitates the traceability of products in the event of a safety incident and enables a faster and more efficient recall of IVD products.
In addition, the IVDR Regulation places higher demands on technical documentation and clinical evaluations. These must now be more detailed. The regulation also requires manufacturers to carry out performance studies and demonstrate that their products meet the requirements of the respective risk class in terms of safety and performance. This assessment must also be continued after the product has been placed on the market in order to identify potential safety risks at an early stage and be able to respond to them.
Requirements & transition periods for IVD products
- List D products: until December 31, 2027
- List C products: until December 31, 2028
- List B products and sterile list A products: until December 31, 2029
- Products with an existing notified body certificate: until May 26, 2025
- In-house devices: until May 26, 2024 (with possible extension until 2028)
Requirements for the transition period
- Declaration of conformity according to IVDD before May 26, 2022
- No significant changes to the product
- Implementation of IVDR-compliant monitoring and vigilance
- Registration in EUDAMED
We are happy to support you with the quality assurance of your in-vitro diagnostics and the fulfillment of all regulatory requirements. In this way, we ensure that you can go through the conformity assessment process for your medical devices and in-vitro diagnostics efficiently and smoothly.
We are your "Experts in IVD"
Extensive experience & expertise
Years of experience in the global approval of IVDs and in-depth understanding of complex regulatory requirements.
Committed & knowledgeable employees
Highly qualified team with a passion for IVD regulation and customized solutions.
Proven track record in audits
Numerous successful approvals and satisfied customers testify to our expertise.
Seamless compliance & market launch
Comprehensive support from development to market launch for efficient and compliant product placement.
Continuous support & advice
Long-term partnership with proactive advice on regulatory developments.
Step by step to success
FREE PRELIMINARY TALK
INTERNAL AUDIT / GAP ANALYSIS
PROCESS ANALYSIS
FOLLOW-UP OF THE AUDIT
PASSING THE EXTERNAL AUDIT: CERTIFICATION
We guide you through every step of the process, regardless of the market in which you want to market your IVD product
Case studies: Our success stories

Rapid market approval of a diabetes diagnostic in the EU thanks to comprehensive regulatory support
Task
A medium-sized company wanted to launch an innovative in-vitro diagnostic for the early detection of diabetes on the European market. The company was faced with the challenge of meeting the complex requirements of the EU IVD Regulation (IVDR) and at the same time entering the market as quickly as possible.
Solution
MEDAGENT was commissioned to handle the entire approval process. This included creating the technical documentation, carrying out the risk assessment, preparing the clinical evaluation documents and communicating with the notified bodies. MEDAGENT also coordinated the necessary tests and supported the company in implementing a quality management system in accordance with ISO 13485.
Result
Thanks to MEDAGENT's comprehensive support, the company was able to successfully complete the approval process within the planned timeframe. The product received CE marking and was launched on the European market without delay. This enabled the company to gain market share early on and quickly amortize the investment costs.

Successful global market launch of an infectious disease diagnostic through coordinated approval strategy
Task
A global company was planning to launch a new in-vitro diagnostic for the detection of infectious diseases in several international markets, including the USA, Japan and Australia. The company needed support in complying with the different regulatory requirements of these countries.
Solution
MEDAGENT was responsible for coordinating the global approval strategy. This included adapting the technical documentation to the respective country-specific requirements, preparing and submitting the marketing authorization applications and communicating with the relevant health authorities. MEDAGENT also ensured that all clinical data and studies complied with international standards.
Result
With MEDAGENT's help, the company was able to successfully complete the approval process in the targeted markets without any major delays. This enabled a simultaneous market launch of the product in several countries, which led to a significant increase in global market presence and sales. The company benefited from an efficient and smooth approval strategy that saved both time and costs.
Benefit from more than 25 years of expertise
With offices in Germany, USA, UK and Brazil, our team of 30 experts is a reliable partner in the field of approval and process consulting with a focus on medical technology for more than 300 international customers.
Our goal is to promote the regulatory quality and effectiveness of medical device companies through diligence and innovation to provide our clients with a fast and reliable path to certification of their medical devices or IVDs.
FAQ - We are frequently asked these questions
The IDVR came into force on May 26, 2022. Regardless of the transitional periods set, various requirements have thus become mandatory for IVD manufacturers. These include the obligation to monitor products on the market, vigilance and monitoring by the competent authorities. Even if products were still placed on the market under the IVDD, the entire Chapter VII of the IVDR must be applied. All actors must also be registered in the EUDAMED. During the transitional periods, no significant changes may be made to the design of the devices or their intended purpose, as otherwise the requirements of the IVDR must be applied directly and in full.
Placing on the market is the process by which a product is manufactured and sold by the manufacturer or importer to another legal entity. It is not absolutely necessary for the physical product to change hands. All further sales of the product after it has been placed on the market, for example from a retailer to an end consumer, are regarded as making available on the market. Both placing on the market and making available refer to each individual product and not to a general product type, regardless of whether the product was produced as a single item or in series.
This means that individual devices placed on the market after the IVDR comes into force must comply with the requirements of the IVDR, even if the same device model or type was already available before the IVDR came into force.
The IVDR is a regulation. The IVDD is a directive. In contrast to directives, regulations are directly valid and legally binding in all EU member states with an enforcement effect for the individual, without the need for implementation into national law.
The IVDR Regulation introduced numerous changes to the regulatory requirements for IVDs (in vitro diagnostic medical devices) in the EU. These changes require massive investments (in time, resources and funding) on the part of manufacturers to meet the new requirements. In addition, not all guidance documents, implementing and delegated acts have been published yet. IVD manufacturers are therefore well advised to keep up to date with all changes to the IVDR and work with their Notified Bodies to ensure the timely testing and approval of their products.
Notified bodies must assess the conformity of all devices except class A. Their requirements have been significantly increased by the IVDR:
- Determine product classification
- Adapt QM system
- Create technical documentation
- Involve notified body
- Carry out a conformity assessment
When introducing in-vitro diagnostics to the market, manufacturers must prepare the necessary technical documentation and ensure that the products are labeled accordingly. The labeling must contain information on product identification, origin and use.
The IVDR is a regulation with direct legal effect in all EU member states, whereas the IVDD was a directive that had to be implemented nationally. The IVDR sets significantly higher requirements for safety and performance.
The requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR) apply to the placing on the market of in vitro diagnostic medical devices in the European Union. Manufacturers must carry out a conformity assessment and consult a notified body to ensure the conformity of their products.
Manufacturers are obliged to ensure the conformity of their in vitro diagnostic medical devices and to keep the documentation available. Importers must ensure that the products comply with European requirements. Distributors are responsible for ensuring that the products are correctly labeled and documented.
To ensure that in vitro diagnostic medical devices meet the required standards, manufacturers must carry out quality controls and testing procedures in accordance with the requirements of the IVDR Regulation. This includes performance testing and validation of product performance.
The transitional periods for placing in vitro diagnostic medical devices on the market under the IVDR vary depending on the risk class of the products. Depending on the classification, the deadlines extend until 2025, 2026 or 2027. It is important to check the specific compliance requirements and deadlines in connection with the respective products and their classification.
- Process validation (DQ, IQ, OQ, PQ)
- UDI implementation and EUDAMED registration
- CE conformity assessment
- Risk management according to ISO 14971
MEDAGENT provides comprehensive services, including the preparation and submission of regulatory dossiers, advice on regulatory requirements, risk assessment and management, and ongoing support and advice throughout the regulatory process.
MEDAGENT has in-depth knowledge of the global regulatory landscape and can help you comply with all relevant regulations and standards to successfully register your IVD products in international markets.
Working with MEDAGENT leads to faster market approvals, minimizes risks, saves costs and ensures the highest level of compliance security, which ultimately leads to a competitive advantage and increased customer satisfaction.
The duration of the approval process can vary depending on the complexity of the product and the specific requirements of the target markets. MEDAGENT works efficiently and purposefully to complete the process as quickly as possible.
MEDAGENT is characterized by extensive experience, dedicated and knowledgeable staff, a proven track record, seamless compliance and market launch, and ongoing support and advice. These factors make us your ideal partner for the approval of in-vitro diagnostics.