Medical devices: what you need to know about the new European Regulation

The health crisis linked to COVID-19 has prompted public authorities to postpone the entry into force of European regulation 2017/745 on medical devices by one year, to 26 May 2021. This is an opportunity to make sure we properly understand what it contains and have the right tools for compliance. Two such tools are CE marking and ISO 13485.

Caution should be exercised with regard to implants and medical devices in general. Various scandals, for example the breast prosthesis scandal in the early 2010s, have led to tighter regulations. The principle: have manufacturers demonstrate that they control risks throughout the life cycle of their products. It is in this spirit that the European Union has enacted regulations 2017/745 (for medical devices, including active implantable devices) and 2017/746 (for in vitro diagnostic medical devices).

Regulation 2017/745, derived from European Directives 90/385 (active implantable devices) and 93/42 (medical devices), was to take effect on 26 May 2020. The public authorities have granted a one-year reprieve because of the COVID-19 health crisis which has disrupted many organizations. The French National Agency for Medicines and Health Products Safety (ANSM) lists the key points:

  • The scope is extended to non-medical devices
  • New obligations are imposed: one person is responsible for ensuring that the manufacturer complies with the regulations
  • Notified bodies are placed under European control and subject to new procedural obligations (unannounced visits to manufacturers, product controls)
  • Regulation of the sector at European level put in place with a coordination group for national authorities
  • The vigilance system is improved with the establishment of a European incident database
  • The framework for clinical investigations is consistent with the framework applicable to medicinal products for clinical trials
  • Pre-market assessment is strengthened
  • Certainpractices are regulated such as the production of medical devices in health establishments and the reprocessing of single-use devices
  • Transparency and traceability are improved

The objective is to demonstrate that risks are controlled throughout the product life cycle. And at the start of the life cycle, there is placing on the market. At this stage, a procedure is required: CE marking. This compulsory marking, recognizable by the small “CE” logo with letter shapes based on circles, gives the products concerned the right to move freely throughout the European Union, signifying that these products comply with the relevant European regulatory texts (directives or regulations).

In order to affix the CE marking, the manufacturer must carry out or have carried out laboratory inspections and tests proving this conformity, in particular in the field of health and safety. In the field of medical devices, this procedure applies to all market players, i.e. any natural or legal person who manufactures, refurbishes, has designed or has manufactured a medical device and markets it under its name or brand. Note: the CE marking is not a certification mark, nor an indication of the geographical origin of the product.

AFNOR Certification: issuing the CE mark in 2022

It was logical that AFNOR Certification, a specialist in recognition of quality and confidence, should position itself as a notified body for affixing the CE marking on medical devices. This has now been progressed with its recent application to ANSM, the French National Agency for Medicines & Health Products Safety, in order to become the second French notified body for this service and thus offer its regulatory compliance assessment services to manufacturers. “The CE marking is essential for French manufacturers to market their medical devices on the territory of the European Union. We will mobilize all our rigour and expertise to certify compliance of products with the essential health and safety requirements,” explains Anthony Delamotte, Director of the AFNOR Medical business unit at AFNOR Certification. The group already has a notified body to offer CE marking with Berlin Cert. It is expected that AFNOR Certification will itself become a notified body in the first half of 2022.

In the meantime, AFNOR Certification continues to offer the other essential tool for medical device manufacturers: ISO 13485 certification. By displaying this distinctive sign of certification based on the standard of the same name (in its latest version, that of 2016), they immediately reassure their customers about their ability to control risks within the meaning of the European regulation. You can get training on it and even become an auditor so that you too can issue the certification to organizations requesting it. For this, approach our teams!

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