What is a medical device?
Contact lenses, compresses, hip replacements… There are many types of medical devices, which are classified into four categories based on their level of risk. Considered a health product, medical devices are strictly regulated. They are used to diagnose, prevent, monitor, treat, and alleviate a disease or injury. Unlike drugs, medical devices are considered non-pharmacological, non-immunological, and non-metabolic. However, they may be supplemented or supported by such treatments. Note: Before being marketed in the European Union, a medical device must meet certain criteria and obtain the CE mark, which guarantees its regulatory compliance.
Obtaining the CE Mark for medical devices
How can you determine which class a medical device falls under?
The classification of medical devices is harmonized at the European level. It is divided into four classes. The manufacturer is responsible for selecting the appropriate class before the device is placed on the market. Each class has specific evaluation and control requirements:
- Class I (lowest risk category): eyeglasses, vehicles for people with disabilities, crutches…;
- Class IIa (moderate/low potential risk): contact lenses, ultrasound devices, dental crowns, hearing aids…;
- Class IIb (high/significant potential risk): condoms, contact lens disinfectants, hemodialysis machines…;
- Class III (highest risk category): breast implants, stents, hip replacements…
Why do we refer to medical devices as active, implantable, invasive, or in vitro?
There are several types of medical devices: non-implantable, implantable, custom-made, and in vitro diagnostic devices.
- Implantable or invasive medical devices is permanently implanted in the patient’s body through surgery. This is the case with hip replacements and breast implants, for example.
- Active implantable medical device refers to a device that requires a power source to operate. Examples include pacemakers and defibrillators.
- Custom-made medical device : This is the case with orthopedic insoles, for example.
- In vitro diagnostic medical device is used to make a diagnosis or assist in medical monitoring: monitoring blood glucose levels in people with diabetes, pregnancy tests, biomedical analyses, etc.
Is my software a medical device?
The medical community is increasingly using software for patient care. These solutions are constantly evolving and improving the quality of care. The European Union’s Medical Devices Regulation includes software when it is specifically used for diagnostic or therapeutic purposes. Considered active devices, they must fall into one of the four official classes (categorized from lowest to highest risk) based on their potential risk to the human body. Software can operate on its own or in combination with another medical device.
What is the difference between standards and regulations for medical devices?
As with any other product or service, the standards and regulations governing medical devices differ in terms of their origin and application:
- Regulations are issued by public authorities. They are the embodiment of a law or a regulation, and compliance with them is mandatory.
- Standards are voluntary in nature. Compliance with them is not mandatory (with rare exceptions where regulations refer to them).
- For medical devices, there is a European regulatory framework that sets out a number of safety and performance requirements: Regulation (EU) 2017/745. Compliance with this regulation is mandatory for marketing products on the European market.
- At the same time, manufacturers can rely on harmonized standards, which enable them to demonstrate that their products meet safety and performance requirements. While these standards are not mandatory, they make it easier to demonstrate compliance.
Who develops standards for medical devices?
Standards are developed by a committee of experts within a standards commission. Thus, it is professionals in a given sector who draft the standards. Each commission is unique and is formed based on the specific field under consideration. Following a thorough review and analysis, a vote is held to establish a standard that enjoys consensus within the commission. This standard then becomes the benchmark for the field in question.
Standards can be national or international in scope. For example, standards for medical devices are adopted by European standardization bodies, with France represented by AFNOR. These bodies operate under a mandate from the European Commission but remain independent. Each Member State first defines its position within its national standards committee, and then the same process of seeking consensus is carried out at the European level. The NF EN 60601 standard on electromedical equipment followed this process. Standards developed at the international level bear the prefix “ISO.”
What does European Regulation 2017/745 say?
Regulation 2017/745 establishes common rules and obligations for all stakeholders involved in medical devices operating in Europe. The goal is to eliminate operational disparities among EU countries and provide greater transparency for consumers.
It entered into force on May 26, 2021, and applies to all EU member states. In particular, this regulation provides for more rigorous pre-market assessment of medical devices and stricter post-market controls. This oversight is carried out by independent bodies designated by national authorities, such as AFNOR Certification, and subject to European oversight.
For economic operators listed in Regulation (EU) 2017/745 (e.g., medical device manufacturers, authorized representatives, 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 (e.g., Article 10 of Regulation 2017/745 for manufacturers) and to the safety or performance of the medical device (e.g., Annex 1 of Regulation 2017/745 for manufacturers).
What is the purpose of the CE marking for medical devices?
CE marking is mandatory for any medical device intended for sale in EU member states. It certifies that the product complies with the essential requirements for safety and clinical benefit set forth in Regulation (EU) 2017/745, which cover, in particular:
- the manufacturing process
- quality assurance
- compliance with applicable regulations
Easily recognizable by its two-letter "CE" logo, it provides consumers with a genuine guarantee of the medical device's reliability and quality.
The CE marking is mandatory for all new products placed on the market in the EU and will be mandatory for all existing medical devices starting in 2028.
Who can issue the CE marking for medical devices?
With the exception of Class I devices, for which a simple self-declaration is sufficient, all other categories of medical devices must undergo conformity assessments by a European notified body authorized by the European Commission.
Notified in April 2024, AFNOR Certification’s scope of designation for Regulation (EU) 2017/745 is available on the European Commission’s website NANDO .
In accordance with its status as a Notified Body, AFNOR Certification is committed to handling 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?
View an ISO 13485 certification is a globally recognized competitive advantage. It enables medical device manufacturers to demonstrate their ability to manage risk throughout the medical device’s lifecycle by implementing an effective 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 guidelines and recommendations aimed at ensuring that medical devices are safe, effective, and in line with customer requirements and regulatory standards.
What is a quality management system for medical devices?
Regardless of the field of application, the quality management system (QMS) aims to bring together all the elements necessary for the success of a product or service. It also establishes a process to ensure compliance and continuous improvement. With regard to medical devices, the ISO 13485 standard of April 2016 provides a set of guidelines and recommendations for every stage of the medical device’s or service’s lifecycle. It ensures that medical devices are safe, effective, and compliant with both customer requirements and regulatory standards. Finally, ISO certification offers a significant competitive advantage.
Who is responsible for ensuring compliance with regulations at my company?
The European regulation governing medical devices requires manufacturers and industry professionals to designate a responsible person whose role includes ensuring that medical devices comply with the relevant provisions. Within the organization, this individual must possess the necessary skills to carry out this role effectively. There are two options for selecting the right candidate:
- or hold a degree in law, medicine, pharmacy, or engineering, and have at least one year of professional experience in the field of regulation or quality management systems related to medical devices;
- or have four years of professional experience in the field of regulation or quality management systems related to medical devices.
In any case, continuing education are available for those interested in becoming a regulatory compliance officer or quality manager.
Who is responsible for managing the quality of medical devices at my company?
Rely on the ISO 13485 standard enables manufacturers and professionals in the medical sector to demonstrate their risk management capabilities throughout the medical device’s lifecycle. To be effective, this voluntary certification of the quality management system must be managed and organized within the company concerned, under the responsibility of senior management. This is to “provide evidence of its commitment to the development and implementation of the quality management system (QMS) as well as to maintaining its effectiveness,” as stated in the standard.
To this end, a designated contact person must be appointed. This person must:
- ensure that the processes related to effective quality management are properly documented;
- report to management on the effectiveness of the QMS and any necessary improvements.
- ensure that all internal stakeholders are aware of the requirements so that we can effectively comply with regulatory standards.
To identify the right candidate within the company, it is recommended to consider training opportunities. For example, there are continuing education programs available for those seeking to become quality managers.
