EU IVDR Notified Bodies – An Indispensable Part of the CE Marking System

The CE marking regulation for IVD medical devices, commonly known as the EU IVDR, is soon going into effect on May 26^th, 2022. Notified bodies hold key responsibilities and are an indispensable part of the CE marking system.

Manufacturers cannot place any products on the European Economic Area (EEA) without a CE mark. Notified Bodies are the organizations designated by the Competent Authority of an EU member country for assessing and certifying products before they are placed on the European markets or put into service. They are responsible for carrying out conformity assessments by conducting audits against the relevant directives or regulations and the European regulatory standards. They also are required to review the technical documentation and are sometimes obligated to get them verified in laboratories.

Thus, Notified Bodies ascertain that the manufacturer’s products meet the regulatory requirements and provide manufacturers with CE certificates of conformity. The manufacturers sign a Declaration of Conformity and apply the CE mark (with or without the Notified Body number), thus granting them authorization to access European markets.

There are twenty two notified bodies designated under the IVD Directive 98/79/EC. However, this does not mean that all of them are designated under the IVDR. They need to apply for designation and qualify under the IVDR after they meet certain criteria.

The procedure to designate independent bodies responsible for carrying conformity assessments of products is called “notification” and so conformity assessment bodies are “notified bodies”!

In the IVDR, Chapter IV (Articles 31 to 46) and Annex VII describe in great detail the minimum requirements to be fulfilled by a Notified Body applying to be designated by a Competent Authority IVDR assessments.  These requirements have increased drastically compared to the IVDD. Some of these criteria are around their organizational structure, legal status, and finances. There are several specific requirements to be met related to competency i.e., having sufficient and qualified resources with the necessary level of knowledge and experience to evaluate the IVD medical devices subject to review. These are the requirements that have been consistently difficult to meet. Other criteria specify the details for quality management systems, sub-contracting, external experts/SMEs, and so on. Henceforth, notified bodies will be subject to a peer review and a complete re-assessment to determine whether they still satisfy the requirements every three years after notification, and again every fourth year thereafter. Clearly, the scrutiny of the notified bodies has increased multi-fold.

Annex VII stresses that notified bodies must maintain strict confidentiality and impartiality during assessments. Overall, the requirements have increased and as a result, fewer notified bodies have applied for IVDR designation.

The  NANDO, or the New Approach Notified and Designated Organisations database/website, provides us the exact details of which notified bodies are designated under the IVDR, as well as other information:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

There were twenty two notified bodies designated under the IVD Directive, however, we currently have only six notified bodies for the IVDR!

Table 1: Notified Bodies for EU IVDR.

Compared to the IVDD, notified body involvement has increased drastically and is required for almost 80% of IVDs, except those belonging to Class A (non sterile), the lowest risk class. Manufacturers of medical devices have the liberty to choose their notified body. Here, it is important to note that all notified bodies may not be designated for the full scope of the IVDR and may not provide all the services required by a manufacturer. They are designated for specific regulations and directives, specific device classes, technologies, and disease areas and thus, the manufacturer must select their notified body with care. Also, manufacturers must ensure that the notified body of their choice has a qualified staff that is experienced enough with the product to be certified. Notified bodies are usually located in the EU, but other entities like TGA Australia and SQS Switzerland may also be authorized to function like notified bodies under the Directive. Sometimes, they may have subsidiaries in other countries as well.

Notified bodies have been given four-digit identification numbers which are to be included by the manufacturer on the labels of the products certified by them.

For eg., BSI group Netherlands has 2797.

BSI Netherlands is designated for the following codes (this is an illustrative example, not the complete list)

Once the manufacturer has engaged with a notified body, here are some of the critical activities they perform, some of which are based on risk class and the selected conformity assessment route:

• Review of the manufacturer’s application and formalize a written contract
• Allocation of resources for the conformity assessment process
• Planning
• QMS audit
• Product verification if required
• Assessment of Technical Documentation based on a sampling plan covering the range of devices manufactured
• Review of significant changes
• Assessment of the GSPRs – safety and performance requirements as per Annex I
• Clinical data and performance evaluation data
• PMS data
• Benefit – risk analysis
• Certification, Monitoring, re-certification activities

• Range of products manufactured
• Risk class and intended purpose
• Novelty of design
• Complex manufacturing process
• Previous audit findings
• PMS, complaints, deviations

Notified bodies will conduct a surveillance audit of the manufacturer every year and an unannounced audit once every five years. They may even audit sub-contractors and critical suppliers if the need arises.

EUDAMED, which is the European medical device database, has a module specifically for Notified Bodies where the certificates will be uploaded. It is one of the key aspects of the EU IVDR, and it fosters an ease of communication when sharing information between various stakeholders.

Notified Bodies have been instrumental in reducing the burden placed on the Competent Authorities for the CE marking process. As a result, the Competent Authorities can focus on supervision and monitoring. The new regulations aim at improving the efficiency of the CE marking process. With the implementation of the new IVDR, more than 80% of the IVDs in the market require notified body involvement. This is a drastic change compared to the IVDD. The conditions and criteria to be met by notified bodies have increased dramatically. Additionally the scrutiny of the manufacturers by the notified bodies and the scrutiny of the notified bodies themselves by competent authorities have been intensified, with the focus being on patient safety. Consequently, a dwindling number of notified bodies have opted for designation under the IVDR, creating a major bottleneck. In this situation, with such a small number of notified bodies managing the certification of the entire IVD industry, delays in placing devices on the European market can be expected. This could lead to shortages of devices for healthcare institutions. Given this situation, manufacturers need to act quickly to engage with an IVDR designated notified body and prepare for the implementation of the IVDR.