The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into force on 25 May 2017 and will be implemented from 26 May 2022. From the date of implementation, the IVDR will replace the former In Vitro Diagnostic Directive (IVDD) 98/79/EC.
Within the EU, medical device manufacturers will have to adapt their products, documentation, and production processes to The EU Medical Device Regulation（MDR）and IVDR to be able to offer them in the European Economic Area (EEA). So, what does this mean in practice?
PART 01
What is The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)?
The IVDR has been elevated from a directive to regulation at the regulatory level, redefining the concept of in vitro diagnostic devices (IVD), including the classification as well as the approval and monitoring process, to establish a sound, transparent, predictable, and sustainable regulatory framework for the in vitro diagnostic medical industry. This marks a further focus by the EU authorities on the regulation of the medical device sector and heralds a further harmonization of standards in the regulation of medical devices across the EU member states.
Because the IVDD relies on a predetermined list of medical conditions, it is unable to respond effectively to the emergence of new lethal pathogens and the associated mass deployment of self-diagnostic tests. The current situation requires a different regulatory regime, which the IVDR aims to provide.
PART 02
What are the main changes from IVDD to IVDR?
The EU zone is one of the core target markets for various medical device manufacturers and the second largest in vitro diagnostic device market in the world. For medical device companies interested in selling their products in the EEA, there is a need to further clarify the change from IVDD to IVDR and to ensure that the latest Quality Management System (QMS) meets the requirements of IVDR.
1. Changes in classification rules
In the IVDR regulation, all in vitro diagnostic devices are classified into four categories from low to high, A, B, C, and D, based on product risk. This classification rule is derived from The Global Harmonization Task Force (GHTF) and is the most recognized classification rule on an international scale.
2. The involvement of Notified Bodies (NB)
Along with the adjustment of the product classification rules, the certification route for each type of product has naturally changed a lot compared to the original regulatory system, the core change point of which is the increase in the intervention of Notified Body (NB), which involves some products in category A and all products in category B, C and D. Across the IVD sector, the number of products involving Notified Body involvement has increased from 10%-20% under the IVDD regulatory system to 80%-90%. The increase in notified body involvement means that market access for the vast majority of in vitro diagnostic devices, in the EU zone, will be a substantial registration process. As of May 1, 2022, there are 7 notified bodies for CE certification of medical devices that have obtained the new IVDR qualification.
3. Establishment of a medical device database (Eudamed)
Under the IVDR, one of the most important tasks for the EU authorities is the future launch of the Eudamed database, which will cover a wide range of important information from pre-market approval to post-market surveillance of products.
4. Introduction of the Unique Device Identification System (UDI)
The UDI proposed in the IVDR consists of a fixed Device Identifier (DI) and a non-fixed Production Identifier (PI). In the process of implementing the UDI, manufacturers need to specify the UDI code and the information contained in each product, put a UDI sticker on the product and store the UDI-related information in electronic form and declare it on the Eudamed system to enhance product traceability and post-market management.
5. The introduction of a regulatory officer
For the first time, the IVDR regulation requires the appointment of at least one regulatory officer within each manufacturer's enterprise to handle product-related regulatory and compliance-related tasks and to act as a liaison between the medical device company and the designated authority.
Specific responsibilities include product batch release, drafting and maintaining CE technical documentation, completing post-market product monitoring, and signing off on clinical trial-related documentation.
PART 03
Products regulated by the IVDR
With the increasing number and importance of diagnostic medical devices, these higher standards are intended to improve public health and safety. van Drongelen et al. estimate that only 15.9% of medical diagnostic products will receive this lower risk class under the IVDR (Class A), while 84.2% will receive one of the higher risk classifications. These higher risk classifications require notification to the approval body to assess the manufacturing and quality control processes to ensure the safety of the product and compliance with the IVDR requirements for this category. As a result, many products that did not require an extensive regulatory approval process under the IVDD will have to be re-approved under the IVDR.
Example: SARS-CoV-2 diagnostic test
An example illustrating the change in regulatory focus is the SARS-CoV-2 diagnostic test. As SARS-CoV-2 is not listed in the IVDD, these tests are subject to the lowest level of regulatory review, requiring an EC Declaration of Conformity without any regulatory validation. However, they are classified as Class D products under the IVDR as they are high-risk pathogen tests for patients and the broader population and therefore face the highest approval criteria required by the IVDR.
PART 04
CE marking is the passport to the EU market
CE marking is a passport for products to enter the EU market and circulate freely throughout the EU, representing that the product complies with the EU laws, regulations, and standards relating to the product.
The IVDR is an in vitro diagnostic medical device regulation issued by the EU on 5 May 2017 to replace the former IVDD. After the transitional period for the implementation of the regulation, in vitro diagnostic medical devices that have not obtained the IVDR CE certification will no longer be able to be placed on the EU market.
The new regulation aims to establish a modern and stricter regulatory framework to better protect the health and safety of the public and patients. The IVDR regulation, therefore, imposes stricter requirements on manufacturers' quality systems and the safety, efficacy, and post-market surveillance of products than the IVDD Directive, and requires products to meet traceability from production to the endpoint.
With the strength of its R&D innovation and perfect quality system, Hutchison Health will obtain the IVDR CE certificate issued by the EU Notified Body under the IVDR regulation for the UltraFast QPCR Instrument (HC800), UltraFast QPCR Instrument (HC1600) and the accompanying Specimen Release Agent.
