The vast majority of medical device manufacturers who seek to sell their devices in Europe must work with Notified Bodies. To many manufacturers for whom Europe is a brand-new market, the regulatory scheme and the role of the Notified Body are sometimes difficult to comprehend. This is because the European CE marking process is different from the medical device approval process in the United States, and a close comparison can be difficult without years of expertise in different regulatory arenas.
One way the two regulatory schemes are different is the role of the Notified Body. Even if third parties exist in several regulations, a European notified body has a precise scope of actions and responsibilities in the framework of the EU MD regulation. Typically experts in European directives and standards, Notified Bodies evaluate the conformity of products and the associated quality systems for manufacturers that seek to sell products in Europe. Additionally, there are things that Notified Bodies must do, and there are other activities that they must not do in order to keep their “notification.” Finally, because there are so many Notified Bodies, it is important to keep in mind some points when choosing a Notified Body that will help bring your device into Europe.
Why Are They Called “Notified Bodies?”
A Notified Body is an independent certification organization that is “notified” by a European Member State’s Competent Authority to determine if a product or system meets applicable requirements for CE marking. The Competent Authorities, for medical devices, are usually the individual Member States’ Ministry of Health, or an agency within the Ministry of Health. The European Commission is the executive branch of the EU, and is responsible for the Directive’s proper execution. Each country (Member State) has its own Competent Authority in charge of market surveillance and designating and monitoring the independent Conformity Assessment Bodies. The European Commission lists these designated Conformity Assessment Bodies. The procedure to designate and list the Conformity Assessment Bodies is called “notification,” hence the name “Notified Body.” Competent Authorities continually assess Notified Bodies to ensure that they maintain their competence and expertise to a directive. LNE/G-MED is a leading Notified Body that is notified to conduct conformity assessments for European directives related to medical devices, including the MDD, the AIMDD, and the IVDD.
This scheme is shared by all “New Approach” European Directives requiring the CE Marking of specific products. Not all Competent Authorities have designated Notified Bodies for all medical device directives: some have designated one, and some have designated several of them. The list of Notified Bodies, their scope of notification, and the list of Competent Authorities are available on the NANDO website.1 Despite the fact that a Notified Body is designated by the CA of a particular country, they issue certificates intended to allow the free movement of goods within the EU. The manufacturer therefore doesn’t need to duplicate the assessment for each country he intends to sell to. These “New Approach” Directives, as a result, took down barriers to trade within the EU, making it easier to sell goods not only for the individual Member States, but for importers as well. In addition, for medical devices, this guarantees the free movement of devices within the internal market and harmonized the individual national requirements for protecting safety and health.2
Where Does the Notified Body Fit in the Registration Scheme?
The Notified Body provides premarketing and routine conformity assessment services for a manufacturer’s device and quality system. The ultimate goal of the Medical Device Directive and other regulations is to answer to the highest level of public health. The certificates issued by the Notified Body must therefore be the evidence of reliable and trustable assessment as mandated by the Directive for the specific medical device class. Notified Bodies take this responsibility seriously, as a medical device manufacturer usually needs a certificate from a Notified Body to be able to declare conformity for their device and affix the CE mark. So, without the certificate (and the CE Marking), a medical device cannot be sold in the EU. The Notified Body assesses the device and quality system to ensure it was created and is operated within the EU legislation and directives. Notified Bodies have no enforcement power beyond issuing, maintaining, suspending, and withdrawing certificates. The market surveillance and actual enforcement remains the Competent Authority’s jurisdiction. To assess the device and the quality system, the Notified Body follows the assessment route that the manufacturer chooses, with respect to the device class. Not all medical devices require the services of a Notified Body, for example, the lowest-risk devices, that are “self-declared as conform to the regulation requirements” by the manufacturer.
What do Notified Bodies Do and how are They Important?
What Notified Bodies Do
The Notified Body’s primary task is to provide conformity assessment services according to the directives, taking into account all the relevant guidance documents and standards. These activities include:
• Confirming the manufacturer has classified its device correctly according to the classification rules in the MDD or the IVDD;
• And depending on the class
o Verify the product through sampling, testing, or release batch testing;
o Certifying and auditing a manufacturer’s quality management system;
o Performing the technical documentation assessment, either systematically, for the highest risk products, or on a sampling basis for medium risk products; and
o Auditing critical sub-contractors.
The quality system audits aim to verify that the manufacturer defined, documented, and implemented a coherent set of policies, procedures, and practices to control and manage their activities. These quality systems must demonstrate that the applicable regulatory requirements are included. The technical file review aims to verify the relevance of the technical documentation built by the manufacturer as their demonstration that the product complies to all applicable Essential Requirements in the Directives. The favorable assessment of the quality system and/or the technical file allow the Notified Body to issue the corresponding CE certificates, necessary for the manufacturer to issue its CE Declaration of Conformity. Ultimately, the manufacturer is responsible to CE mark the device after verifying that all requirements are satisfied once all the Notified Body’s necessary assessments, where applicable, favorably conclude by issuing a CE certificate.
How a Notified Bodies’ Activities are Important
A Notified Bodies’ activities and responsibilities are important because the conformity assessment procedure services can be a prerequisite for CE marking. To carry out these and other responsibilities, the Notified Body must be competent in the directives for which it provides conformity assessment procedure services. The Competent Authorities of each Member State examine the organization when determining if it is competent for a specific directive. Specifically, the Competent Authorities examine:
• The availability and expertise of the organization’s personnel and equipment;
• The organization’s independence and impartiality in regards to those personnel directly or indirectly concerned with the product;
• The technical competence of the people relevant to the products and the conformity assessment;
• How the organization maintains its professional confidentiality and integrity; and
• If the organization has civil liability insurance, unless the liability is covered by the Member State according to national law.3
It is important to note that Notified Bodies must always be independent from their clients and other interested parties. A Notified Body can, however, exchange technical information with one of its clients as part of its assessment.4 Even though a Notified Body can be either private or state-owned, its independence, impartiality, and integrity are very important.5
Some parties expressed concerns about Notified Bodies’ assessments due to their number, the fact that they compete with each other, and their apparent lack of independence from the manufacturer that pays for their assessment services. Some Notified Bodies, nevertheless, take full responsibility for their assessments and agreed to raise the bar through establishing and implementing the Notified Body Code of Conduct.6 The Code of Conduct was first issued in February 2011 and is still being extended. LNE/G-MED was one of the five Notified Bodies who originally developed the document. The document’s purpose is to improve the implementation of the European CE certification of medical devices through clarified organizational criteria and competence of assessment practices. Also, per the Directive, the Notified Bodies are required to meet at least twice a year within the NB-MED Group and share about practices and develop recommendations aimed at harmonizing their practices. It should be noted that in April 2012, European Commissioner John Dallí gave his support to the CoC initiative as a mean to improve and reinforce the regulatory system and expressed his wish that all Notified Bodies commit to adhering to this Code of Conduct.
What a Notified Body Can’t Do
For the many responsibilities that Notified Bodies have, there are some limits to their activities. These limits are mostly in place to protect a client’s information and ensure the Notified Body maintains its independence and integrity for the conformity assessment process. The Notified Bodies’ limits on their activities are the negatives of their requirements, or what a Notified Body cannot do in order to fulfill their requirements. First, to fulfill its impartiality requirement, a Notified Body cannot also be the manufacturer, the European authorized representative, a supplier, a competitor of the client. A Notified Body also cannot offer consultancy services or advice for the design, construction, marketing, or maintenance of the products for which it also provides conformity assessment services.7
Notified Bodies also have a requirement to stay independent, meaning the Notified Body and any subcontractors should be “impartial and free from engagements and influences, which could affect their objectivity…”8 One way to ensure their independence is that Notified Bodies also require that all staff declare any potential conflict of interest.9 This is to ensure no economic factors can influence the Notified Body’s decision for providing CE marking for a device. Ensuring the information they receive remains confidential is another requirement. While Notified Bodies have a duty to disclose some information to Competent Authorities, they also have a duty of confidentiality with regards to everyone else.10 Notified Bodies take these requirements seriously as they understand their important role and responsibility in CE marking a medical device manufacturer’s product.
Enforcement for Notified Bodies, the Assessed Assessors – The Relationship between a Notified Body and its Competent Authority
Notified Bodies play an important role in CE marking a medical device manufacturer’s product, and the role that the Competent Authorities have underlines this importance. Competent Authorities continually assess Notified Bodies through communications and audits. Competent Authorities may even accompany Notified Bodies on audits sometimes in order to ensure the Notified Body follows the appropriate audit practices. Notified Bodies report to the competent authorities of the member state that originally notifies the Notified Body. For example, LNE/G-MED reports to ANSM, the French Competent Authority. The methods and criteria for assessing Notified Bodies were clarified, beyond the requirements for the directives, in the Best Practices Guides issued by the Notified Bodies Operations Group (NBOG) and in their “Designating Authorities Handbook.”
Additionally, Notified Bodies must routinely communicate with the Competent Authorities regarding their assessments and the issued certificates. Notified Bodies must communicate about the certificates they issue, modify, withdraw, or suspend, and for whom and which products. In addition, upon request, Notified Bodies must also provide any information about assessments performed supporting a certification decision. Finally, the Notified Bodies must also get an opinion from the Competent Authority as part of the assessment of a product that incorporates a drug, a human blood derivative, or a product or animal origin that is covered by Directive 2003/32/EC. The Notified Body must also inform the Competent Authority of any significant change to its organization. Just as a medical device manufacturer is assessed by a Notified Body, Competent Authorities also assess Notified Bodies.
Things to keep in mind when choosing a Notified Body
Given a Notified Body’s strategic role in your device’s CE marking, there are some criteria that a medical device manufacturer could keep in mind when choosing a Notified Body.
Notification: Some Notified Bodies specialize in a specific Directive for medical devices, while others are notified to all medical device Directives.
Service: Medical device manufacturers are diverse and have widely diverse needs, both with respect to themselves as well as their devices. Medical device manufacturers are welcome to talk to different Notified Bodies and see which ones fit their needs best.
Expertise: Manufacturers should ensure their Notified Body and auditors can understand the device to make an accurate assessment. To understand the device, the Notified Body can have project managers and auditors with expertise and experience on the type of device, such as combination products and products of animal origin.
Reputation: A Notified Body’s reputation and the way it works show how seriously it internalizes its own ethics. For example, a Notified Body may be a member of Team NB, an association of Notified Bodies notified to the medical device directives that promote high standards for Notified Bodies. Team NB promulgated the Notified Body Code of Conduct, to which Notified Bodies could elect to apply to themselves.
Market Access: A Notified Body may also be able to provide market access in many different countries, and not just the EU.
Medical device manufacturers are unique, each with their unique needs for a Notified body. However, by keeping these general criteria in mind, a manufacturer could have a good and long-term relationship with a Notified Body. By incorporating these criteria into its mission statement, LNE/G-MED is a Notified Body that leads in client satisfaction. First, LNE/G-MED is notified to all medical device directives. Second, its wide range of expertise and more than 18 years of experience in CE Marking medical devices ensures that a manufacturer’s dedicated project manager and auditor understand the device and the manufacturer’s needs. Given these considerations and its reputation, LNE/G-MED is the first choice of many medical device manufacturers, and a choice they continue to make for many years. For more information on how LNE/G-MED can partner with you to help bring your device to Europe, contact us.
3 Blue Guide, § 6.1, pg. 36.
5 Blue Guide, § 6.3, pp 39-40.
7 Blue Guide, §6.3, pg. 40.
8 MEDDEV 2.10-2 Rev. 1 pg. 6.