IVD manufacturers that need to market their devices in Europe need a strategy to successfully navigate through the certification process framed by the 98/79/EC directive governing in vitro diagnostic medical devices.
Similar to the Medical Device Directive (MDD), the IVD Directive (IVDD 98/79/EC), includes requirements that govern the device's performance and manufacturing, market placement and demands on safety and quality.
Why IVD manufacturers choose LNE/G-MED?
Notified to the IVD Directive since 2000
LNE/G-MED is notified since November 24th, 2000, with a full scope of tasks which includes all IVD listed in Annex II List A and List B as well as self-tests.
Extensive in-house IVD expertise
As a well-established and respected Notified Body, LNE/G-MED has an in-house IVD expertise and enjoys the ability of guiding a device to market through CE Marking certification process. Part of this ability comes from its large pool of regulatory and technical experts, specialists in all of medical device directives, including the IVD Directive.
The technical documentation of your IVD device is meticulously examined. Data on clinical assessments and analytical performances is submitted to internationally recognized biologists for review, and studies already performed by the manufacturer are assessed for their pertinence.
Certification Project Managers, Reviewers and Auditors located in the United States
When an IVD manufacturer chooses LNE/G-MED to be its Notified Body, it also choses efficiency, transparency and expertise by means of knowledge transfer. IVD manufacturers receive personal attention from their IVD Certification Project Manager and Experts.
Entrust your IVD device now with LNE/G-MED and receive a specialized evaluation to market your device efficiently and effectively.
Trust LNE/G-MED for your IVD Batch release testing
The most appropriate formula is applied for the verification of manufactured products (batch release testing) of your IVD devices. LNE/G-MED will provide you with certificates for all conformity procedures: product design examination, EC type examination, approval and monitoring of the production quality system and batch release testing for products referred to in Annex II list A.
What you need to know about In Vitro Diagnostic Devices
The process outlined in the IVD Directive that allows a manufacturer to enter the European market in accordance with Directive 98/79/EC goes through several stages and involves some choices.
Unsuitable choices can lead to extended delays or increased costs required to obtain certificates and possibly lead to deadlock. Defining the best approach is of strategic importance.
What is an In Vitro Diagnostic device (IVD)?
In vitro Diagnostics Devices (IVDs) are devices that analyze human body fluids to provide critical diagnostic information that helps to prevent and treat diseases.
According to the IVD Directive (IVDD; 98/79/EC), the IVD device provides information:
- About a physiological or pathological state; or
- About a congenital abnormality; or
- Determining the safety and compatibility with potential recipients; or
- Monitoring therapeutic measures.
The definition of an IVD medical device is found in the IVD Directive (IVDD; 98/79/EC) at article 1(2)(b).
Offering In vitro Diagnostics Devices in the European Union (EU) requires compliance with the In vitro diagnostic Directive (IVDD; directive 98/79/EC), which lists devices requiring specific assessments:
- Self-Testing IVD Devices
- Annex II, list A (e.g., blood grouping, HIV screening)
- Annex II, list B (e.g., HLA grouping; detection of Chlamydia, Rubella; monitoring blood glucose).
The involvement of a Notified Body is necessary for IVD medical devices listed in Annex II of the IVD Directive 98/79/EC and for IVD medical devices designed for self-testing.
What is the class of my IVD?
After a manufacturer determines that they have an IVDMD, it must be classified. Although we are not talking about class, in vitro diagnostic medical devices are divided into IVDs that fall within Lists A (screening) and B (diagnosis) of Annex II and those that are not on these lists.
The manual Borderline and Classification version 1.17 (09-2015) provide guidelines for determining the class of an IVD medical devices.
Based on the classification, the manufacturer will then undergo conformity assessments to show that their quality management system meets the regulatory requirements, and that the IVD meets the Essential Requirements of the IVD Regulation.
IVD Conformity Assessment
The conformity evaluation procedures are designed to evaluate compliance with the essential requirements of the directives. They are the main obligations of the manufacturer to place medical devices on the market in the European Market.
The choice of the procedure, which is the manufacturer’s, must be performed as described in Article 9 of Directive 98/79/EC regarding medical devices for in vitro diagnosis.
The Directive includes five annexes (III to VII) describing possible procedure(s) for each type of device. All devices which may have a significant impact on the safety of the patient must be assessed by a notified body.
These include products used for blood or tissue donation, detection of infectious diseases (particularly in the fetus), self-monitoring of blood glucose by diabetics, diagnosis of phenylketonuria, dosage of prostatic hormones, and screening for trisomy 21, plus self-testing devices intended for the general public. Products must be reassessed every five years.
Why should IVD manufacturers select a Notified Body for their ISO13485 certification?
The European directives require the manufacturer to implement a quality management system for IVDMDs. EN ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes) is the European Harmonized standard on this matter. Specific attention should be paid to the European foreword of this standard.
Indeed, Annexes ZA, ZB and ZC of EN ISO 13485:2016 show the comparison between the chapters of the standard and the requirements of the annexes of the Directives.
More information about what a QMS is expected to be can found in the following guidance documents: NBOG BPG 2010-1 and NBOG BPG 2010-2 (http://www.nbog.eu/nbog-documents/).
IVD manufacturers whose devices do not currently require the intervention of a notified body for CE Marking have been postponing the implementation of an ISO 13485-compliant QMS. With the recast of the IVD European regulation, most IVD manufacturers will need the intervention of a notified body in order to CE mark their devices.
This will have also a direct impact on their QMS. For more information on how LNE/G-MED can help you achieve EN ISO 13485 certification, contact us.
How can LNE/G-MED help IVD manufacturers?
LNE/G-MED is an established and well-respected notified body (CE 0459) and Health Canada-recognized registrar that was notified to the IVD Directive since its inception.
LNE/G-MED’s combined audits make it easy for an IVD manufacturer to be audited for EN ISO 13485, ISO 13485 – MDSAP, and CE Marking at once, potentially saving lives by making market access more efficient for the manufacturer.
These attributes make LNE/G-MED an easy choice for IVD manufacturers, their products in Europe in marketing and beyond.
IVD Borderline Medical Devices
The differences among the international in vitro diagnostic (or IVD) medical device regulatory schemes can be confusing, especially when one jurisdiction views a device differently than another. It’s important to stay within the lines of the jurisdiction’s regulation and definitions of what it considers to be an IVD.
That said, there are a few products that may, at first blush, fit within the EU’s definition of what is an IVD medical device, but they are specifically excluded from the scope of the IVD Directive. These devices are called borderline devices, and IVDs aren’t the only types of medical devices that can have them. However, the borderline for IVDs can sometimes be a bit more difficult to see.
The Revision of the European regulatory scheme for IVDs brought major changes to the ways that IVDs are marketed and registered in Europe. The changes with the most impact are to the classification scheme and the conformity assessment procedures for IVDs.
The IVD classification scheme is expected to change from an exclusive, list-based system to risk-based classification scheme with four classes (A to D) and seven classification rules to determine which IVD belongs in which class.
Future IVD classification system
The proposed regulation introduces four risk-based classes, based on the GHTF classification of medical devices: A, B, C, and D.
IVDs are classified into one of these classes by taking into account their intended use, the risk of the disease or condition for which they test, their novelty and complexity, and the inherent risks to using the device itself
Low individual risk, low public health risk
Moderate individual risk and/or low public health risk
High individual risk and/or moderate public health risk
Blood glucose self-testing
High individual risk and high public health risk
Changes to the conformity assessment procedures for IVDs
Along with the classification changes came changes to the conformity assessment procedures. IVDs in Classes D, C, and B now all require the use of a Notified Body in performing a part of the conformity assessments for the device. The obvious immediate consequence is that many more IVD manufacturers will need the involvement of a notified body in order to access the European market.
Selecting a notified body for both ISO13485 certification and CE marking will help IVDs manufacturers to avoid dealing with multiple certification bodies and multiple annual audits.
This represents a huge change for IVD manufacturers selling their products on the EU market, as it could prompt restructuring and additional testing and documentation for their products to stay on the market. It is important that IVD manufacturers monitor these changes as the proposed regulations continue to move through the process in order for their products to stay on the market.
Planning ahead and monitoring the regulatory evolutions as they come in order to absorb the changes more easily will help IVD manufacturers maintain their products’ conformity with the EU regulatory scheme, wherever it ends up.
IVD Training Course
LNE/G-MED offer trainings tailored to In-Vitro Diagnostics manufacturers through multiple platforms: On-site training course, E-learning and Online webinars.
Check our list of IVD courses and training.
• IVD Technical File Documentation
• CE Marking for IVD devices
• Evolutions in the EU IVD Regulatory Framework