In vitro diagnostic medical devices, or IVDs, are critical medical devices that can be used to help the patient, physician, and caregiver in reaching medical decisions. Their growing influence and added value in the worldwide medical device market translates into technological advances and automation to make IVD tests easier to use and more accurate. Evolving in this global market is a more and more challenging regulatory environment. Already-existing regulatory schemes tend to implement more competent authority controls and/or certification body. Most of these regulations require the implementation or risk management principles and activities within a quality management system (QMS).

Voluntarily conforming to ISO 13485 is the best way for an IVD manufacturer to prepare to access the market worldwide. Being ISO 13485 certified by an independent third party is even better to reach this goal and provide the confidence that all the efforts to conform to this standard have been successful.

What Is ISO 13485?
ISO 13485 (Medical devices – Quality management systems – requirements for regulatory purposes) is an internationally recognized standard for a medical device manufacturer’s QMS. It is widely recognized as a way to answer QMS requirements of regulations worldwide. For example, EN ISO 13485 is the European harmonized standard for a medical device manufacturer’s QMS. This standard is harmonized to all three of the European medical device directives, including the IVD Directive. As another example, ISO 13485 within the CMDCAS program is recognized by Health Canada as part of the registration process for certain classes of IVD devices in Canada. There are many other jurisdictions that recognize or even require ISO 13485 certification in order to access their market. For example, ISO 13485 certification may be used as evidence of a conforming QMS in China, Australia, and Japan.

Why Select a Notified Body for ISO 13485 Certification?
In addition to consideration of cost, expertise, and responsiveness, it is important to be aware that not all certification bodies are equally recognized by the regulatory competent authorities. It is therefore essential to carefully select the appropriate certification body.

A notified body is a body involved in the conformity assessment of medical devices and the associated quality management systems for manufacturers that seek to sell their devices in Europe. In the current European regulatory framework, only high-risk IVDs require the involvement of a notified body in order be CE marked (HIV assays, Hepatitis B and C assays, PSA assays, self-testing assays, etc.)

However, the majority of IVDs do not currently require the intervention of a notified body for CE Marking because their manufacturer self-certifies their products according to the IVD Directive. This also sometimes leads IVD manufacturers to postpone implementing an ISO 13485-compliant QMS with a device. With the upcoming IVD European regulation changes, most IVD manufacturers will need the intervention of a notified body in order to CE mark their devices.

The Revision of the European regulatory scheme for IVDs [.PDF] 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 changes 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. 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 ISO 13485 certification and CE marking will help IVDs manufacturers avoid dealing with multiple certification bodies and multiple annual audits.

For example, an IVD manufacturer makes point-of-care (POC) IVDs to test for patient’s blood gases. Under the new classification scheme, these devices could be Class C (through Rule 4) devices, which require the involvement of a notified body. Even though the revisions to the IVD Directive will not be implemented for a few years, the manufacturer should consider implementing an ISO 13485-certified QMS to keep opened markets and ease access to Europe later. Because it is a European harmonized standard for the new crop of IVDs that must be certified and receive CE Marking from a notified body, building a compliant QMS and receiving the certificate is a key first step for an IVD manufacturer to comply with the revision.

As another example, another IVD manufacturer makes molecular diagnostic (MDx) devices that test for certain sexually transmitted infections, such as herpes and the human papillomavirus (HPV). Under the new classification scheme, these IVDs could also be Class C devices (through Rule 3), requiring the involvement of a notified body. This manufacturer should also consider implementing an ISO 13485-certified QMS to be ready before the Revisions’ changes block its devices from the European market. Even though the IVD Regulation won’t be enforced for the next few years, IVD manufacturers can get a head start on building, implementing, and certifying their ISO 13485-compliant QMS now. This way, the IVD manufacturer can work out any QMS challenges before a looming deadline that can affect CE Marking and market share.

Why Select a Canadian Registrar?
IVD manufacturers shall be ISO 13485 certified within the CMDCAS program in order to market their devices in Canada for certain classes of devices (II, III and IV). In order to obtain such a certificate, the manufacturer shall select a registrar specifically recognized by Health Canada according to the Canadian Medical Device Regulation. Selecting a certification body that is both a notified body and a Canadian registrar will allow the manufacturer to access a larger market while minimizing time and cost by using a single certification body.

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 notified to the IVD Directive since its inception. LNE/G-MED is also Third Party Accredited Person by the U.S. FDA for QSR audits, recognized by Taiwan’s Ministry of Health within a technical cooperation program (TCP Program) under which LNE/G-MED is recognized for certification of European production sites.

LNE/G-MED’s combined audits make it easy for an IVD manufacturer to be audited for EN ISO 13485, ISO 13485 – CMDCAS, and CE Marking at once. It’s an easy choice for IVD manufacturers looking to market their products in Europe and beyond.

The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of IVD Medical Device Directive 98/79/EC (IVDD) are expecting to lead to a fully remodeled regulation. For information on the new requirements so far and the changes that could be coming, manufacturers can tune to LNE/G-MED North America’s upcoming FREE webinar, Evolutions in the EU IVD Regulatory Framework, on April 16 at 2:00 PM ET.

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