The Journey of a Medical Device
Regulatory and Clinical Affairs: 4 key elements
Date
03/31/2023
Regulatory and Clinical Affairs: 4 key elements
Date
03/31/2023
To access the market, a medical device (MD) must have been CE certified.
The certification process raises many related questions for healthcare manufacturer.
Is my product a medical device?
What regulatory requirements must be met?
How long does it take to obtain CE certification?
...
Once a product has been classified as a medical device, and according to its risk class, a winding road begins on the horizon in order to bring it to the European market.
There are four key elements:
1 - Go-to-market strategy
Regardless of the type of MD, the applicable regulations define a triptych of elements required (QMS / DT / Clinical) to obtain CE marking:
In the eyes of the regulatory authorities, the introduction of these elements attests to the professionalism of manufacturers and the reliability of the medical devices they provide on the market.
Validation of these elements differs according to the MD's class.
For further information on MD classification:
The go-to-market strategy involves :
The key challenge of this strategy is to establish the most optimal roadmap to ensure that the product is launched on the market as quickly as possible, with the necessary and sufficient documentation to obtain CE marking, and at optimized costs.
An adapted and anticipated market access strategy, based on the specific features of each product, is a real asset for the manufacturer, both economically and in terms of competition.
2 - Product compliance
As stated above, medical device compliance depends on the validation of several documents making up the QMS/DT/Clinical triptych.
This stage is the responsibility of the product manufacturer, who can consult specialized structures to support them.
Setting up a quality management system (QMS) within the company
The reference standard is ISO13485:2016. This is an industry standard built specifically for the medical device sector, which specifically calls for demonstrating control of the risk associated with an activity and the traceability of a product to ensure its reliability.
The Quality Management System is a complex element in its constitution, requiring patience and accuracy. It is the first structural step in ensuring confident market access.
It represents an opportunity to be embraced by project leaders, and a major asset for a company's development, since it enables processes to be set up to ensure the continuity of activities, based on the principles of continual improvement.
Technical documentation for the product
The technical file documents all the product's characteristics, its design and development processes, the risks associated with its use... In short, the product is examined to ensure that it works properly and is safe for users.
Documentation of clinical evaluation/product performance, attesting to the device's safety related to human variability.
The aim of clinical/performance evaluation is to demonstrate that the variability of living organisms has been taken into account in the design of the product, and that the intended use is appropriate. The goal is to demonstrate the device's clinical or public health benefits, while assessing its safety in use.
The compliance phase is the operational phase associated with the market access strategy defined above. It is used to build up the evidence required to obtain CE marking.
3 - Procedures with the notified body
Within the European Union, a notified body is a third-party structure nominated by a Member State to determine whether a product to be brought to market complies with specific regulatory requirements. It generally carries out a conformity audit, which may include inspection of a product, its design, as well as the production environment and related processes.
The choice of NB is left to the manufacturer. Early contact is recommended, as procedures and audit scheduling times can be long, depending on the context.
An optimized go-to-market strategy includes taking into account the challenge that has impacted NBs since the new regulations came into force (EU MDR 2017/745 and EU MDR 2017/746).
The relationship with the NB can be long-lasting, and depends on the operating procedures specific to each organization. However, 2 major events are part of a framework of common procedures:
4 - Post-market surveillance
Obtaining the CE mark authorizes the manufacturer to bring his medical device to the European market, but it remains the manufacturer's responsibility to ensure that his product remains compliant over time.
Since the new regulations were introduced, the requirements regarding the lifecycle of products after certification have been introduced/reinforced.
CE marking does not mean the end of the process! The QMS must be maintained in compliance, a regulatory monitoring system must be set up, internal audits must be carried out every year, materiovigilance information must be reported if necessary, and post-market clinical follow-up must be planned and carried out.... And a NB visit every 5 years is required for renewal of CE certification.
Other questions may also arise during the life of a medical device:
Do I want to access international markets?
Do I want my product to be reimbursed?…
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This article is provided for information purposes only and does not constitute a normative or regulatory reference.
