Medical devices in the European Union (EU) are approved through a different mechanism than the approval process in the United States or Canada. The approval of medical devices intended for use with a medical purpose in the EU must undergo a conformity assessment to demonstrate that they meet the legal requirements for safety and performance. The CE (Conformité Européenne) mark can then be placed on a medical device when it passes this conformity assessment. The regulation of medical devices is designed to be regulated at the state level and the European Medicines Agency (EMA) might be involved in the regulatory approval process for certain products.

The conformity assessment involves an audit from the EU Member States designate accredited notified bodies for the manufacturer’s quality system and the technical documentation on the safety and performance of the device. Notified bodies have the authority to approve the conformity assessment and issue a CE certificate, but must seek a scientific opinion from the EMA if the product falls within the following categories:

• Combination product (i.e. medicinal products that include a medical device).
• Medical devices with an ancillary medicinal substance.
• Companion diagnostic (in-vitro diagnostic devices).
• Medical devices made of substance(s) that are systemically absorbed.
• Borderline products between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines, and food supplements.
• It falls within the scope of the centralized procedure for the authorization of medicines.

However, in some cases, the notified body may seek scientific opinions from the National Competent Authority as well. For example, for medical devices with an ancillary medicinal substance that is not derived from human blood or plasma, or does not fall within the scope of the centralized procedure for the authorization of the medicines, the notified body can seek opinions from a National Competent Authority. Also, the classification of borderline products should be evaluated by a National Competent Authority to determine the applicable regulatory framework.

All classes of medical devices should pass the conformity assessment and be issued with a CE certificate by an accredited Notified Body, except for Class I medical devices that are not sterilized, not equipped with a measuring feature, or not reusable surgical instruments. The exempted Class I medical devices (low-risk) do not need to involve a notified body and can be self-declared and self-certified by the manufacturer.

Given the classifications and types of medical devices, the governing regulations can differ significantly from one another. If you would like to learn more about the regulations on medical devices or need help becoming compliant, contact us today.