We bring in-vitro diagnostics to the market for manufacturers & distributors
Do you no longer want to struggle with the requirements of the IVDR yourself, but instead rely on the expertise of specialists? MEDAGENT ensures that you meet all the requirements of the IVDR easily and reliably.
FAST
Thanks to our comprehensive expertise and efficient processes, we accelerate the market approval of your IVD products both nationally and internationally.
Safe
We know the regulatory requirements inside out. That's why we can avoid errors and delays and minimize risks.
Economical
Our support and precise planning help to avoid unnecessary costs and rework, resulting in financial savings.
Clever
Through our network and access to up-to-date information, you can access specialist knowledge and expertise on regulatory changes.
We have helped these customers gain a competitive edge
Our services
Implementation of QM systems
Upgrade of the existing QM system in accordance with the requirements of the IVDR
Classification of IVD products & software
List A, List B, List C and related conformity assessment procedures conformity assessment procedures
Technical documentation
Support with technical documentation in accordance with Annex II and III of the IVDR
Process validation
Qualification according to DQ (Design Qual.), IQ (Installation Qual.), OQ (Operation Qual.) and PQ (Performance Qual.)
Unique Device Identification (UDI)
UDI implementation for your IVD products: Basic UDI-DI, UDI-DI, UDIPI, EUDAMED
CE conformity
Preparation for and guidance through the conformity assessment procedure
Risk management
Strategy for risk management in accordance with ISO 14971 and postmarket surveillance
In vitro diagnostics
In-vitro diagnostics (IVDs) are medical devices such as instruments, devices and reagent products that are used to carry out tests and analyses outside the human body in order to obtain information about a person's state of health, for example.
In Europe, the in vitro diagnostic medical devices regulation (EU) 2017/746 (IVDR) regulates the placing on the market of medical devices from the in vitro diagnostics group.
In order to be able to sell IVDs on the European market, you as a manufacturer must meet numerous requirements. The transition from EU Directive 98/79/EC (IVDD) to IVDR (EU) 2017/746, which has been in force since 2017, means a significant increase in regulatory requirements for IVDs and therefore a considerable amount of additional work for you.
What does this mean for IVD manufacturers in concrete terms?
In the interests of patient safety, products are assigned to risk classes. Many products have been upgraded. This increases the requirements for many IVD products.
In addition to the new classification system, there is also a grouping into "patient-oriented tests", products for self-administration (by patients/laypersons) and so-called "companion diagnostics" (often abbreviated to "CDx").
In addition to the existing labeling regulations for medical devices, the unique product identifier is mandatory.
The quality management system must meet the requirements of IVDR (EU) 2017/746. In addition to the requirements for the QM system contained in the regulation, Annex ZB of EN ISO 13485 for IVDs has been adapted accordingly.
Manufacturers must now precisely plan and implement post-market surveillance (as part of the QM system)
The topic of software was only dealt with superficially in the IVDD. In contrast, the development, verification and validation of the software used is now an integral part of the IVDR
Requirements & transition periods for IVD products
The following deadlines apply:
Products that were placed on the market before May 26, 2022 with a self-declaration (Declaration of Conformity, i.e. without the involvement of a Notified Body) and for which the involvement of a Notified Body is now required under the new regulation may still be placed on the market or put into service in the EU until the following dates in accordance with the IVD Directive:
Products on list D until December 31, 2027
Products on list C until December 31, 2028
Products on list B and products on list A that are placed on the market in sterile condition until December 31, 2029
Devices placed on the market before May 26, 2022 with a certificate issued by a Notified Body can still be placed on the market or put into service in accordance with the Directive until May 26, 2025.
"In-house devices" (laboratory/clinical IVDs)- have a transition period until May 26, 2024 and, if justified by the unavailability of an equivalent CE-marked device, until May 26, 2028.
However, the prerequisite is that the manufacturer:
has already issued a declaration of conformity in accordance with the IVDD before May 26, 2022.
will not make any significant changes to the design, manufacture or intended use.
has implemented post-market surveillance (Articles 78-81, Annex III) and vigilance (Articles 82-87) in accordance with the IVDR.
has registered its product in EUDAMED in accordance with the IVDR.
Why is MEDAGENT the right partner for you?
Save time and money with MEDAGENT!
The IVDR is undoubtedly a challenge for IVD manufacturers and distributors. Meeting the requirements of the IVDR is complicated and time-consuming.
You should therefore rely on MEDAGENT as your partner for all aspects of your IVD products. Because with us, you save your internal resources and have a reliable expert at your side - in all matters relating to the approval and certification of IVDs.
We are your "Experts in IVD"
Competitive advantages
MEDAGENT's fast and efficient approval procedures give you a head start in the market.
Risk minimization
Sound expertise and experience minimize the risk of approval errors and delays.
Customer satisfaction
The highest quality standards and timely market launches lead to satisfied customers.
Employee motivation
Relieving your employees of complex regulatory tasks increases their motivation and efficiency.
Cost savings
Precise planning and implementation save costs by avoiding unnecessary rework.
Compliance security
Constant monitoring and adherence to legal requirements guarantee maximum compliance security.
Flexibility
Adaptable strategies and individual solutions ensure smooth project execution.
Long-term partnership
MEDAGENT offers continuous support and advice for sustainable success and growth.
Step by step to your success
No matter in which market you want to market your in-vitro diagnostics product - we design, support or optimize your processes and ideas with our experience and expertise.
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 20 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.