IVDR Classification and Regulatory Changes
The In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC previously outlined limited involvement of Notified Bodies for a few high-risk IVDs listed in Annex II. However, the In Vitro Diagnostic Medical Devices Regulation (IVDR) introduces a risk-based classification system, ranging from Class A (lowest risk) to Class D (highest risk). The new regulation includes seven classification rules specified in Annex VIII of the IVDR.
Increased Third-Party Oversight:
A notable outcome of this regulatory change is that the majority of IVDs will now require the involvement of a Notified Body for conformity assessment to obtain the CE mark. Additionally, in the case of Companion Diagnostics, a review by a Competent Authority is necessary. Consequently, there has been a significant increase in third-party oversight. Under the IVDD, around 80% of products were self-declared by the manufacturer, whereas under the IVDR, approximately 90% may require assessment by a Notified Body.
Class D classification encompasses general life-threatening conditions and specifically addresses transmissible agents present in blood and biological materials intended for transplantation or re-administration. These tests pose both high personal and public health risks. Examples include screening for transmissible agents and high-risk blood grouping for transfusion, transplantation, or cell administration. Tests for HIV1 and 2, HTLV I/II, Hepatitis B and C, Chagas disease, and syphilis screening in blood are included. Devices for blood grouping and tissue typing to ensure immunological compatibility also fall under Class D.
Class C classification covers a diverse range of high-risk IVD devices that pose a moderate to high personal health risk but a lower public health risk. This class includes tests for infectious diseases, sexually transmitted infections, cancer biomarkers, companion diagnostics, genetic testing, TORCH screening, congenital disorders, and monitoring of high-risk medicines/substances. Most self-test IVDs are included in this class, with exceptions explicitly mentioned in Class B.
Class B classification includes IVD devices that pose a low public health risk but a moderate personal risk. This class covers various devices not specified in other classification rules. Examples include clinical chemistry tests, specific self-test IVDs such as pregnancy tests, fertility tests, and cholesterol tests.
Class A encompasses IVD devices with low public health and personal risks. This class includes laboratory devices, instruments, and specimen receptacles. It covers products for general laboratory use, accessories with no critical characteristics, buffers, washes, culture media, and histological stains (if intended for the specific test), as well as instruments intended for IVD procedures.
The Medical Devices Coordination Group (MDCG) document provides detailed information on the classification rules specified in Annex VIII of the IVDR. Manufacturers should refer to this document for comprehensive guidance on classification criteria.
Conformity Assessment by Notified Bodies:
Under the IVDR, the conformity assessment process for obtaining the CE mark for the majority of IVDs will require involvement from a Notified Body, unlike the self-declaration process under the IVDD. Class A non-sterile devices remain eligible for self-certification. Manufacturers should proactively engage with a Notified Body during the extended transitional period and update their implementation plans accordingly. It is crucial to address devices that do not benefit from the transitional arrangements. If you are facing challenges in finding an operational Notified Body, seek appropriate support and guidance.
The Quality Management System (QMS):
Manufacturers must upgrade their Quality Management System (QMS) to comply with the IVDR requirements. Except for Class A non-sterile IVDs, all device classes will need their QMS and Technical File or Design Dossier audited by a Notified Body. The recognized standard for QMS is ISO 13485, and an audit must be conducted to ensure compliance with the standard's requirements. Upon successfully passing the audit, the IVD manufacturer will receive a CE Certificate and an ISO 13485.
To assist manufacturers in implementing and upgrading their Quality Management Systems, various support services and resources are available. One such organization is AF Pharma Consultants, a renowned consultancy firm specializing in regulatory compliance for the healthcare industry. AF Pharma Consultants can provide valuable assistance throughout the process, including guidance on upgrading your QMS, preparing for Notified Body audits, and ensuring compliance with the IVDR and ISO 13485 standards. Their team of experts can offer tailored solutions to meet your specific needs, helping you navigate the regulatory changes and streamline the certification process.
By partnering with AF Pharma Consultants, manufacturers can benefit from their in-depth knowledge and experience in the field of IVD regulations. With their support, you can enhance your understanding of the requirements, address any challenges you may encounter, and ultimately achieve successful conformity assessment and certification under the IVDR.
Remember, AF Pharma Consultants is available to provide the necessary expertise and support, making your journey toward compliance with the IVDR smoother and more efficient.