The ANSM ensures all medical devices meet their standards for safety, efficiency, and quality. After a 3-year transition period plus a one year extension because of the effects of Covid-19. the MDR took effect in May 2020. EU Regulations 2017/745 and 2017/746 will be effective on the 26th of May 2021. In vitro regulations (IVRD) will go into effect the following year in May 2022.
Manufacturers of medical (MD) and in vitro (IVD) devices must comply with both regulations to receive the CE (European Conformity) marking in French. The CE is necessary for the product to be legally placed in the EU market. Average processing time for a European manufacturer to obtain the CE is 4-6 weeks. Non-Europeans must appoint an EAR (European Authorized Representative) to assist them in getting the CE. There is no charge to obtain the CE which is valid for 5 years. Manufacturers are also required to renew the ISO 13485:2016 certification in French each year.
ANSM regulates the five classes of medical devices (MDs)
- Class I – custom made medical device kits; e.g., stethoscopes and bandages. Technical specifications and conformity test results are required by the ANSM before CE certification.
- Class IIa – Devices implanted in the body for one hour up to 30 days; e.g., hearing aids.
- Class IIb – Devices remaining in body 30 days or more.
- *Class III – Active implants (AIMDs); e.g., pacemakers.
- GMDN: Global Medical Device Nomenclature – used for a generic ID of an uncategorized medical device.
*Manufacturers are also required to prepare a statement of the technical specifications, quality assurance audit, and design approval. This statement or letter goes through the European Notified Body (ENB) to the Regulatory Authority before product is sent to market.
Two-thirds of the income from the medical device industry is generated by small foreign companies. The majority of this income comes from the sales of orthopedic, non-invasive surgery, and disposable medical equipment.