Our SST solutions for medical device companies

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.

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…
   

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.
   

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.
   

Regulation 2017/745 establishes common rules and obligations for all parties involved in the medical device sector 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).

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 for all existing medical devices ( Read our explanations here ).

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. AFNOR Certification has been notified since April 2024, and its 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.

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 a medical device’s or service’s life cycle. It ensures that medical devices are safe, effective, and compliant with customer and regulatory requirements. Finally, ISO certification offers a significant competitive advantage.

ISO 13485 forms the basis of a quality management system for medical devices, while ISO 45001 forms the basis of an occupational health and safety management system, which is not limited to this sector. Quality and occupational health and safety are closely related topics, so much so that both fall under the QSE (quality, safety, environment) umbrella—an area often managed by the same individuals within a company. The concept of quality involves reducing risks, including health risks. However, ISO 45001 takes a more internally focused approach, centered on employees, with the goal of preventing risks, protecting their health, and reducing accidents.