What regulations apply to medical devices?
Patient safety, access to innovation, new care pathways, sovereignty and re-industrialization are all major challenges facing the medical device industry.
In this demanding context, medical device players must be irreproachable in terms of quality management and risk control, and be able to prove it. Indeed, this is the whole point of Regulation (EU) 2017/75, which comes into force in 2021 and imposes a number of safety and performance requirements on manufacturers.
What is regulation 2017 745?
This regulation (EU) 2017/745 is also known as MDR (Medical Devices Regulation). This is a European regulation concerning medical devices, with the main aim of improving the safety and quality of medical devices sold in France and within the European Union. Find out more about Mdr.
The AFNOR Group supports medical device manufacturers by providing expertise, services and support to help them meet regulatory requirements and ensure product conformity.
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Obtain CE marking for medical devices
To market a medical device in the European Union, it is necessary to obtain CE marking, in accordance with Regulation (EU) 2017/745. Depending on the level of risk, a notified body is responsible for assessing conformity. AFNOR Certification, as a French Notified Body, is authorized to carry out an in-depth, impartial and confidential assessment of your medical devices.
Recognition for good medical device management: what is iso 13485 certification?
In addition to the regulatory CE mark, voluntary ISO 13485 certification confirms that you provide a quality service that complies with regulations and the requirements of your customers and partners, not only at the point of sale, but throughout the entire life cycle of a medical device. All in a continuous improvement process. This quality certification is recognized worldwide, beyond the borders of the European Union.
Certify your skills in medical device management
Are you an expert in medical devices, mastering the regulatory framework or the fundamentals of ISO 13485 quality auditing? Have these skills recognized through personal certification. AFNOR Certification takes the exams, and if you pass, confirms your status as an expert in the field. Practical and indispensable for becoming an ICA auditor, for example!
Training in the management of medical devices
Are you a medical device professional? Appoint an in-house risk and quality manager. This person will need to be at the cutting edge of regulations and the standards environment. AFNOR Compétences offers several ranges of training courses:
- Medical device professions (PCVRR or Quality Manager)
- Medical device regulations
- Medical device quality
- Clinical studies
Use voluntary standards specific to medical devices
Risk management, sterilization procedures, testing methods… Numerous standards deal with medical devices. They are available in the AFNOR collection, under the designation NF when they are Franco-French, NF EN when they are European, NF EN ISO or NF ISO when they are international and adopted in France.
At the heart of the corpus is NF EN ISO 13485, which provides guidelines for building a quality management system specific to medical devices, as well as NF EN ISO 14971 on risk management. Other noteworthy standards include ISO 20417, to be published in April 2021, on the information to be provided by manufacturers of medical devices, and S99-300, to be published in July 2021, on the quality approach to medical imaging.
AFNOR is responsible for coordinating the French standardisation system in the field of medical devices. As such, it invites professionals in the sector to co-write standards within some forty specialised standardisation committees, in liaison with European and international standardisation bodies. Examples include the commission on quality management and corresponding general aspects of medical devices (AFNOR/S95B), the commission on active implantable medical devices (AFNOR/S92G) and the commission on clean rooms for medical devices (AFNOR/S91F).
Changing standards for medical devices: monitoring standards and regulations
Design, maintain and market compliant medical devices: CObaz ‘Medical Devices’ is the simple, innovative solution for anticipating, adapting and optimising your products and processes.
Detecting changes and reducing risks
Keep abreast of changes in standards and regulatory texts implemented or to be implemented in your company, and be informed of new texts as they become available.
Quick access to the documents you need
Search for related standards and regulations by directive/regulation in just a few seconds. Our bibliography on medical devices includes AFNOR standards (including drafts), the American AAMI collection and other standards useful for foreign markets, regulatory texts and also the European MDCG and MEDDEV guides .
Save time with innovative services
Classify the relevant documents, identify the normative provisions to be complied with, and the changes between two versions of standards. CObaz medical devices: the centralized solution for sharing information between employees.
