Notified bodies
Assessing the conformity of medical devices before and after their market entry
Date
05/04/2023
Assessing the conformity of medical devices before and after their market entry
Date
05/04/2023
Definition
Within the European Union, a Notified Body (NB) is a third-party structure appointed by a Member State to determine whether a newly released product complies with certain regulatory requirements. It generally carries out a conformity audit, which may include checking a product, its design, as well as the production environment and related processes.
3 milestones in the medical device (MD)/notified body (NB) relationship
In order to market a medical device, all manufacturers must ensure that their product complies with European regulations, and obtain CE certification.
There are several possible routes to this certification:
Obtaining CE marking is a decisive step for manufacturers. Without it, they cannot bring their products to the European Community market.
There are 3 main stages in the relationship between a medical device manufacturer and a notified body:
1. Quality management system conformity audit (ISO 13485)
2. Audit of compliance with regulations (EU) MDR 2017/745 (DM) and (EU) MDR 2017/746 (DMDIV) to obtain CE certification and marketing authorization.
3. Control audits as part of post-market surveillance
The CE marking process for medical devices
To obtain CE marking, the manufacturer must put in place a triptych of elements to ensure the safety and reliability of its DM.
These 3 elements will then be controlled by NBs for DM (class IIa and above).
Once a product has been classified as a medical device, and according to its risk class, a winding road lies ahead before it can be marketed in Europe.
Manufacturers must select a NB from among the 48 organizations designated to date to carry out inspections based on the characteristics of their product. Each NB covers a defined spectrum of expertise, enabling it to audit products according to their specific characteristics.
The choice of ON is left to the manufacturer.
The list of NBs designated to audit under regulations (EU) MDR 2017/745 (DM) and (EU) MDR 2017/746 (DMDIV) can be consulted on the European Commission website.
For example, there are currently 39 NBs able to audit DM and 10 NBs able to audit DM-DIV. Of these two groups of NBs, each will have its own preferred fields of application. The manufacturer will need to choose a suitable NB to audit his product.
To correctly identify the NB that will be able to carry out the audit, the manufacturer can seek advice from a structure specialized in regulatory and clinical affairs, or refer to the code(s) corresponding to its product.
Each device is assigned (source: europa.eu) :
The MDS code is used to select the appropriate ON for checking technical documentation.
The MDT code is used to select the auditor(s) in charge of the on-site audit.
The MDA, MDN, MDS and MDT codes are defined in implementing regulation (UE) 2017/2185.
The ON notification field includes more or less codes, with more or less restrictions (see scopes on the NANDO base).
Traditionally, manufacturers have had to undergo two main types of audit to obtain CE marking, one for their Quality Management System (ISO13485) and the other for their Technical Documentation (MDR 2017/745 or 207/746).
Note: manufacturers are advised to keep a close eye on the market access roadmap, and to anticipate contact with the NB in order to meet its marketing timetable (deadlines for scheduling audits can vary significantly depending on the auditors' workload and the product's characteristics).
At the end of the audit, the manufacturer may be faced with two options:
Renewal of CE marking for medical devices
Obtaining the CE mark authorizes the manufacturer to market his medical device on the European market, but it remains his responsibility to ensure that his product remains compliant over the long term.
Since the new regulations came into force, the requirements inherent in the life of products after certification have been introduced / reinforced. NBs are now also responsible for ensuring that devices continue to meet these requirements: this is known as post-market surveillance.
Post-market surveillance (PMS) is the responsibility of the manufacturer. This involves monitoring a number of activities, collecting data and evaluating them according to predefined performance indicators, notably in the Quality Management System. The aim is to be able to anticipate and quickly detect any need to take action to guarantee the reliability of the device (and its continued market presence). The watchword is to continuously control the risks associated with the use of marketed products.
CE marking is validated by NBs for a limited period (5 years maximum). During this period, intermediate control audits are mandatory every year. In addition, the manufacturer must undergo unannounced audits (1 every 3 years for class III, IIb & I DM, and every 5 years for other classes). At the end of the 5-year period, the manufacturer must apply for renewal of its marking. This process is repeated for each certification cycle.
Post-marketing follow-up is also an excellent opportunity for manufacturers to improve product performance based on real-life feedback.
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This article is provided for information purposes only and does not constitute a normative or regulatory reference.
