In-vitro Diagnostics Regulation correctly applied: These requirements result for your CE-compliant product
Before 2022, three directives regulated medical devices in the EEA: the Active Implantable Medical Devices Directive (AIMDD - 90/383/EEC), the (General) Medical Devices Directive (MDD - 93/42/EEC) and the In Vitro Diagnostics Directive (IVDMDD - 98/79/EC).
The new EU Regulation on in vitro diagnostics (IVDR), Regulation (EU) 2017/746, replaced Directive 98/79/EC. It modernises the legal framework for medical devices and sets stricter requirements. Manufacturers had a transitional period until May 2022 to adjust their documentation and processes.
According to the Regulation (2017/746), in vitro diagnostics (IVDs) are medical devices that examine human body samples outside the body. They provide information on health conditions, genetic aspects, treatment effects and monitoring of therapies. Examples include HIV test kits, blood glucose meters and special sample containers for diagnostic purposes outside the body. General laboratory products are not covered by this category.
IVDR - Regulation on in vitro diagnostics (EU) 2017/746
Q&A
Which EU directives applied to medical devices before 2022?
Medical devices were regulated by three directives in the EEA (European Economic Area) until May 2022.
What is the new EU regulation on in vitro diagnostics and its transitional period?
Two new regulations now replace the above-mentioned directives on medical devices in order to:
What are in vitro medical devices (IVDs)?
The new regulation (2017/746) defines an in vitro diagnostic agent (IVD) as: "medical device used as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, software or system - individually or in conjunction with each other - by the manufacturer for in vitro testing of samples originating from the human body, including blood and tissue donations, is intended and is intended solely or primarily to provide information on one or more of the following
What is the category of medical in vitro diagnostics (IVD) under the old directive?
In the IVD Directive (98/79/EC), IVDs are hierarchically divided into the following four categories according to perceived risk:
What is the new classification for IVDs under IVDR?
In a slight deviation from the IVDD, the IVDR introduces a risk-based classification of classes A to D, where D represents the highest and A the lowest risk category.
What applies to IVD class D products according to IVDR?
The following risk conditions generally apply to Class D products:
What applies to IVD class C products according to IVDR?
Class C includes the following risk conditions:
What applies to IVD class B products according to IVDR?
Class B covers all IVD products that are not specifically covered in other classification rules. These usually include the following products:
What applies to IVD class A products according to IVDR?
Class A comprises laboratory equipment, instruments and sample vessels in the broadest sense. Only Class A devices are approved for self-certification for conformity assessment with the CE marking.
What does the new classification of IVD products mean?
Seven rules describe risk-based IVDR classes that take into account the intended purpose of the products and their inherent risks. In classification, the emphasis is on demonstrating the performance of the product.
What are the challenges of the new IVDR?
Important aspects of Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) that are challenging for manufacturers:
What innovations does the IVDR bring with regard to technical documentation?
The requirements and the expected quality of the technical documentation have increased. The documents are subject to a closer examination by the competent authority (NL).
How do I archive the technical documentation?
Technical documentation should be kept secure and protected from unauthorized access and alteration. Under IVDR legislation, manufacturers are required to keep the technical documentation for CAs/NBs for a period of at least 10 years after the last product is placed on the market.
What innovations does the IVDR bring regarding the general safety and performance principles (SPR)?
The extended version of the Basic Requirements is now referred to as the General Safety and Performance Principles or Requirements (SPR).
What is the UDI system?
The introduction of an UDI system aims to improve the traceability of all medical devices on the market by placing a unique code on the label of the product.
What is EUDAMED?
As part of the IVDR/MDR, EUDAMED serves as a central database for the registration of economic operators and products, but also for vigilance reports and performance studies.
What innovations does the IVDR bring with regard to performance evaluation?
A major challenge of the IVDR is the updated and specified requirements for performance evaluation. It defines a continuous process to provide sufficient clinical evidence to demonstrate that the intended clinical benefit is achieved and the product is safe.
What innovations does the IVDR bring with regard to post-market monitoring?
PMS and in this context Post-Market Performance Follow-Up (PMPF) play an important role within the IVDR. Post-market data must be used to update essential documents, such as risk management and performance evaluation. Manufacturers are required to prepare the relevant documents in accordance with the IVDR, for example the PMS Plan and Report/ Periodic Safety Update Report (PSUR).
How is the CE marking procedure described under the IVDR?
The CE marking procedure for in vitro diagnostics covers two aspects: general compliance and the actual conformity assessment procedure.
How does the conformity assessment procedure for IVD differ from other medical devices?
The CE conformity assessment procedure for IVD is similar to that for medical devices, but there are some significant differences due to the different risks associated with the different products.
How do I get an ISO 13485 certification?
For products other than "A", the QMS and technical documentation must be audited by a European notified body. The CE marking certificate of the device and the ISO 13485 certificate of the production site are issued after successful completion of the 3-party audit. The ISO 13485 certification must be renewed every year, CE marking certificates are usually valid for 3 years.
How are the harmonized IVDR standards developing?
On 15 May 2020, the European Commission published its Implementing Decision M/565 on the development of harmonized standards under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
What are the tasks of the responsible person/expert?
Article 15 of the IVDR clearly states that manufacturers of medical devices are obliged to have within their organisation or at their disposal at least one person who has the necessary expertise in the field of medical devices.
What are the tasks of the authorized representative?
In accordance with Article 11 "the manufacturer of a product not established in a Member State shall designate a single authorized representative". The authorized representative shall provide a copy of the technical documentation, thereby ensuring effective communication with the notified bodies in relation to the manufacturer’s obligations.
What are Notified Bodies for?
Notified bodies (BS) or Notified Bodies (NB) are responsible for ensuring the safety and conformity of all in vitro medical devices placed on the EU market.