How to Obtain CE Marking for Medical Devices

When a product is considered a medical device, to be sold in Europe, it must be CE marked.

It’s not a choice: the concept of “medical device” depends on the use of a product and what it’s sold for. So the manufacturer doesn’t decide whether to consider it as such, and it can’t be anything else. And this applies to any product falling into this category, sold throughout Europe.

To stay true to the topic, let’s start with the assumption that we want to understand how to obtain CE marking for a product that we already know is a medical device. This means omitting an important and not always straightforward part of the discussion, related to product classification, which we will dedicate time to in the future.

The Role of the Manufacturer

The manufacturer is the role played by the company that assumes responsibility for the device and the marking process. It’s not necessary for them to directly handle the design, production, and sales processes, but it’s essential that they have full control over them.

They may not be based in European territory. In such cases, they must enter into a contract with a company based in Europe to represent them and act as an interface with European and national authorities.

The manufacturer’s details appear on the product and its sales packaging.

Implementation of the Quality Management System

A quality management system must be implemented in the manufacturer’s company. The goal is to ensure and demonstrate that they have control over all processes related to the product, even if outsourced.

This translates into the need to comply with the UNI CEI EN ISO 13485:2016 standard and current regulations.

Having a quality management system means defining, for each process, the correct modus operandi in compliance with the above rules and those established internally. Although it can be modified at any time, once implemented, it will be essential to work in compliance with the system, as it is subject to periodic checks by an entity.

Implementing a quality management system takes, on average, 6 months. This is a highly variable timeframe as it’s closely linked to the product and its related processes.

Development of the Technical File

Parallel to the system implementation, to obtain CE marking for a medical device, the manufacturer must proceed with the development of the technical file.

The technical file is not just a collection of documents.

It’s a process that allows achieving and demonstrating the safety and effectiveness of the medical device in compliance with current regulations. Many resulting considerations, in the vast majority of cases, lead to the need to implement product modifications. That’s why it’s important – but not always the case – that its development begins at the start of the design process.

Part of this process may also be linked – depending on the product – to conducting tests at one or more specialized laboratories.

The technical file, in addition to technical specifications, contains: intended use, classification, risk management, type testing, usability, clinical evaluation, labeling project, declaration of conformity, and additional specific content according to the type of medical device.

Generally, the timeframes coincide with those of implementing the quality management system, about 6 months. It remains true that for particularly complex devices, the process can take more than a year.

The Role of the Notified Body

The notified body is authorized by the Ministry of Health and the European Community to carry out the procedures for certification to obtain CE marking for a medical device.
In Italy, there are several bodies, the choice is discretionary, as they are private companies whose services are paid for directly by the manufacturer.

For the sake of correctness, it’s right to say that some classes of medical devices do not require the intervention of the body. The process therefore ends with the development of the technical file.

In other cases, the manufacturer submits the technical file and awaits its evaluation, which is done from a technical and clinical point of view. Subsequently – sometimes concurrently with the evaluation of the technical file – the body plans an audit conducted by one or more assessors, for one or more days, depending on the size of the company. This is a check at the premises of the manufacturer and/or its strategic suppliers, aimed at verifying the correct implementation of the quality management system.

The body is not authorized to provide consultancy, so it’s up to the manufacturer to define how to close any non-conformities that emerge from these assessments.

The two steps above are not simple to manage as they test the manufacturer’s regulatory competence. For this reason, the manufacturer is entitled to seek support from a consulting company that knows in detail the regulatory aspects and the prerogatives of each figure involved.

Issuance of the CE Marking Certificate and Maintenance

Once the audit is completed and the issues related to the quality system and technical file are resolved, the body proceeds with the issuance of the CE marking certificate. This is the formal document that allows the manufacturer to affix the “CE” symbol and sell the medical device in Europe.

All of the above, from the first submission of the technical file to the body, takes approximately 5 months.

The certificate is valid for 5 years.

To keep it active, the body conducts an audit every year at the manufacturer’s premises. Audits with negative outcomes can lead to the revocation of the certificate and the need to withdraw products from the market.
Moreover, the technical file submitted at the beginning freezes the product specifications. Therefore, any changes to it must be approved by the body after evaluation.

At expiration, a longer and more detailed audit is conducted, and the entire technical file is re-evaluated.

Unannounced Audits

In addition to the annually scheduled audits, at least once every three years, the manufacturer receives an unannounced audit. The body has the duty to carry out this activity, which aims to verify the absence of misconduct and deviations from what was declared in terms of production process and product specifications. This activity is also paid for by the manufacturer.

What Happens Next

The above explains how to CE mark a medical device. There are additional aspects that must be fulfilled before actually selling the product and after it has been sold.

In particular, it is necessary to obtain the UDI code and register the product in the Ministry of Health database (in the future, Eudamed), ensure market surveillance and vigilance, and incorporate any technical, clinical, and regulatory updates that impact the product.