For IVD manufacturers and distributors
Meet the requirements of the IVDR - simply and reliably with MEDAGENT.
In-vitro Diagnostics
CERTIFICATION AND APPROVAL OF IVD ON THE EUROPEAN MARKET
In vitro diagnostic medical devices (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.
The in vitro diagnostic medical devices regulation (EU) 2017/746 (IVDR) defines requirements for placing IVDs on the market of the European Economic Community (EEC).
In order to be able to sell IVDs on the European market, manufacturers must meet numerous requirements. Transitioning devices and organizations from the IVDD Directive 98/79/EC, which was in force until 2017, to the IVDR (EU) 2017/746 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?
- Risk-based classification system: 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.
- Risk-based classification system: 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.
- New conformity assessment procedures
- Stringent requirements for technical documentation
- Unique Device Identification (UDI): In addition to the existing labeling regulations for medical devices, the unique product identifier is mandatory.
- Increased involvement and control of the notified body
- Reclassification of already approved IVDs, new certification / conformity assessments required in accordance with current requirements
- Quality management system: The quality management system must meet the requirements of IVDR (EU) 2017/746. In addition to the requirements for the quality system contained in the regulation, Annex ZB of EN ISO 13485 for IVDs has been adapted accordingly.
- The IVDR now defines high demands on the labeling of in-vitro-diagnostics (Annex I, Article 20).
- More stringent requirements for risk management resulting from the IVDR (Annex I.), EN ISO 14971 and ISO/TR 24971.
- Post-market surveillance: Manufacturers must now precisely plan and carry out post-market surveillance activities as part of the quality system.
- Software: In the IVDD, the topic of software was only dealt with superficially. In contrast, the development, verification and validation of the software used is now an integral part of the IVDR.
- The appointment of a "responsible person" is now mandatory.
Would you like to stopp struggeling with the requirements yourself and rely on the technical expertise of experts instead?
Requirements and transition periods for IVD products
In general, the deadline for IVDR compliance is May 26, 2022 for all in vitro diagnostic medical devices whose declaration of compliance is issued after May 26, 2022.
This means that in vitro diagnostic medical devices that do not require a Notified Body under the IVDR, i.e. non-sterile List A devices, must be compliant with the IVDR from May 27, 2022. This also applies to new developments for which manufacturers issue a declaration of conformity after the IVDR comes into force.
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:
- List D devices until December 31, 2027
- List C devices until December 31, 2028
- List B devices and list A devices placed on the market in sterile condition until December 31, 2029
- Devices that were 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 transitional 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 according to IVDD before May 26, 2022.
- will not make any significant changes to the design, manufacture or intended use.
- has introduced 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.
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.
Therefore, rely on MEDAGENT as your partner for all aspects of your IVD products. With us, you can save your internal resources and have a reliable expert at your side – in all matters relating to the approval and certification of IVDs.
Our services for IVD manufacturers and distributors:
IMPLEMENTATION QM SYSTEM
Upgrade of the existing QM system
according to the requirements
of the IVDR
CLASSIFICATION OF YOUR IVD PRODUCTS AND IVD SOFTWARE
List A, List B, List C and related
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 Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification)
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
Risk management strategy according to ISO 14971 and Postmarket surveillance (surveillance after placing on the market)
More than 20 years of expertise in the field of medical devices and in-vitro diagnostics
With offices in Germany, USA, UK and Brazil, our team of 30 experts is a trusted partner in regulatory and process consulting with a focus on medical devices for more than 300 international clients.
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.
We are happy to help you with the quality assurance of your in-vitro diagnostics and with the fulfillment of regulatory requirements so that you can quickly and easily complete the conformity assessment process for your medical devices and in-vitro diagnostics.