FAQ Medical devices

What is a medical device?

Contact lenses, compresses, hip prostheses… There are many medical devices, classified into 4 categories according to their level of danger. Considered a healthcare product, medical devices are strictly regulated. It is used to diagnose, prevent, control, treat and alleviate disease and injury. Unlike drugs, medical devices are considered non-pharmacological, non-immunological and non-metabolic. However, they can be supplemented or assisted by this type of care. Please note: Before a medical device can be marketed in the European Union, it must meet certain criteria and obtain the CE mark, which guarantees its regulatory conformity.

How do you know which class a medical device belongs to?

The classification of medical devices is harmonized at European level. It is organized into 4 classes. The manufacturer is responsible for selecting the category before marketing. Each category has its own specific assessment and control rules:

• Class I (lowest risk class): prescription glasses, vehicles for the disabled, crutches… ;
• class IIa (potential moderate/measured risk): contact lenses, ultrasound equipment, dental crowns, hearing aids, etc. ;
• class IIb (potential high/important risk): condoms, contact lens disinfectants, haemodialysis machines… ;
• class III (highest risk class): breast implants, stents, hip prostheses, etc.

Why do we talk about active, implantable, invasive or in vitro medical devices?

There are several types of medical device: non-implantable, implantable, custom-made or in vitro diagnostic.

• The implantable or invasive medical device is fully implanted in the patient’s body, via surgery, over the long or short term. This is the case for hip prostheses and breast implants, for example.
• An active implantable medical device is one that requires an energy source to operate. These include pacemakers and defibrillators.
• Custom-made medical devices: orthopedic insoles, for example.
• In vitro diagnostic medical devices are used to make a diagnosis or contribute to medical monitoring: blood glucose monitoring for diabetics, pregnancy tests, biomedical analyses, etc.

Is my software a medical device?

More and more frequently, the medical world is using software to manage patients. These solutions are constantly evolving and improving the quality of care. The European Union regulation on medical devices includes software when it is specifically used for diagnostic or therapeutic purposes. Considered as active devices, they must fall into one of the 4 official classes (categories from lowest to highest risk) according to their level of potential risk to the human body. Software can work alone or in conjunction with another medical device.

What’s the difference between standards and regulations for medical devices?

As with any other product or service, standards and regulations for medical devices differ in origin and application:

• Regulation is the responsibility of the public authorities. It is the expression of a law or regulation, and its application is mandatory.
• Standards are voluntary. Complying with them is not an obligation (with rare exceptions when regulations refer to them).
• For medical devices, there is a European regulatory framework that sets a number of safety and performance requirements: European Regulation 2017/745. Compliance with these regulations is a prerequisite for marketing products on the European market.
• At the same time, manufacturers can rely on harmonized standards to demonstrate their products’ compliance with safety and performance requirements. These standards are not mandatory, but make it easier to demonstrate compliance.

Who sets the standards for medical devices?

Standards are drawn up by a committee of experts within a standardization committee. So it’s the professionals in a given sector who write the standards. Each commission is different and is set up according to the environment to be studied. After a thorough process and study, a vote is taken to define a standard that meets the consensus of the commission. It will become the reference in the field.

Standards can be national or international in scope. For example, standards for medical devices are adopted by European standards bodies, with France represented by AFNOR. They act on behalf of the European Commission, but remain independent. Each member state first defines its position within its standards committee, then the same consensus-building process is carried out at European level. The NF EN 60601 standard for electro-medical equipment followed this process. Standards developed at international level carry the prefix “ISO”.

What does European regulation 2017/745 say?

Regulation 2017/745 defines common rules and obligations for all medical device-related players operating in Europe. The aim is to eliminate operating disparities between EU countries and bring greater transparency to consumers.

Coming into force on May 26, 2021 , it applies to all EU member states. In particular, this regulation provides for better pre-market assessment of medical devices and stricter post-market controls. This monitoring is carried out by independent bodies appointed by national authorities, such as AFNOR Certification, and placed under European supervision.

For the economic operators listed in Regulation (EU) 2017/745 (e.g. medical device manufacturers, agents, distributors), the term “regulatory requirements” encompasses the requirements contained in any law applicable to the user and must be limited to requirements relating to the quality management system (example: Article 10 of Regulation 2017/745 for manufacturers) and to the safety or performance of the medical device (example: Annex 1 of Regulation 2017/745 for manufacturers).

What is the purpose of CE marking for medical devices?

CE marking is mandatory for all medical devices wishing to be marketed in EU member states. It attests to the product’s compliance with the essential safety and clinical benefit requirements laid down by Regulation (EU) 2017/745, covering in particular:

• the manufacturing process
• quality assurance
• compliance with current regulatory provisions

Easily identified by its two-letter “CE” logo, it provides consumers with a real guarantee of the reliability and quality of a medical device.

CE marking is compulsory for all new products marketed in the EU, and will be compulsory from 2028 for all existing medical devices.

Who can issue CE markings for medical devices?

Except for Class I, for which simple self-declaration is sufficient, all other DM categories must undergo conformity checks by a European notified body authorized by the European Commission.

Notified since April 2024, AFNOR Certification’s scope of designation for Regulation (EU) 2017/745 is available on the European Commission’s NANDO website.

In accordance with its status as a Notified Body, AFNOR Certification undertakes to treat all requests with the same rigor, the same level of expertise, the same impartiality and the same confidentiality.

What is the purpose of ISO 13485 certification?

ISO 13485 certification is a globally recognized competitive advantage. It enables medical device manufacturers to demonstrate their control of risk throughout the life cycle of the medical device, thanks to the implementation of a high-performance quality management system.

This certification is issued by an independent third-party organization such as AFNOR Certification, following an on-site audit to verify compliance with a set of instructions and recommendations designed to deliver safe, effective medical devices that meet customer and regulatory requirements.

What is a quality management system for medical devices?

Whatever the field of application, a quality management system (QMS) aims to bring together all the ingredients necessary for the success of a product or service. It also initiates a process to ensure compliance and continuous improvement. About medical devices,
the ISO 13485 standard of April 2016
provides a set of guidelines and recommendations for all stages in the life cycle of a medical device or service. It enables us to present medical devices that are safe, effective and compliant with customer and regulatory requirements. Finally, the ISO stamp offers a significant competitive advantage.

Who is responsible for ensuring compliance with regulations in my company?

The European regulation governing medical devices requires manufacturers and professionals in the sector to appoint a person responsible for ensuring that medical devices comply with the relevant provisions. Within the plant, this employee must have the necessary skills to carry out this mission. There are two ways to select the profile:

• or have a degree in law, medicine, pharmacy or engineering, and at least one year’s professional experience in the field of regulations or quality management systems relating to medical devices;
• or have four years’ professional experience in regulatory affairs or quality management systems relating to medical devices.

In all cases
training courses are available
to become a regulatory compliance officer or quality manager.

Who are the people in charge of quality management for medical devices in my company?

Based on
ISO 13485 standard
enables manufacturers and medical professionals to demonstrate risk management throughout the life cycle of a medical device. To be effective, this voluntary certification of the quality approach must be steered and organized within the company concerned, under the responsibility of management. This is to ” provide evidence of its commitment to the development and implementation of the quality management system (QMS) and to maintaining its effectiveness “, says the standard.

To this end, a dedicated contact person must be appointed. It must :

• ensure that processes related to quality management are properly documented;
• report to management on the effectiveness of the QMS and any improvements to be made.
• ensure that all internal parties are aware of the need to meet regulatory requirements.

To choose the right profile for your company, it’s a good idea to go through training. As a result
continuing education courses
to become a quality manager.

Consult our thematic dossier on medical devices