Is your product a medicinal product, a medical device, or both?
No-one who works in the field of medical devices could have avoided hearing about the new Medical Devices Regulation (MDR). After a long drafting process, a transitional period and a delay caused by the COVID-19 pandemic, the MDR will enter fully into force on 26 May 2021.
All of the publicity received by the new Regulation is justified considering how historic a change it represents. The new classification rules will make a large number of new products and applications subject to CE marking. The new Regulation also includes more specific and stricter requirements as well as many new requirements related to aspects such as quality management systems, the demonstration of clinical conformity and the monitoring of safety and quality.
People who work in the field of medicinal products have probably noticed a convergence between the requirements governing medical devices and products registered as medicinal products. The development of new technologies makes this an inevitable trend.
When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.
Determining which legislation a product falls under is essential. However, this is not always straightforward. In addition to assessing the legislation governing medicinal products or medical devices, it may also be necessary to assess the legislation governing areas such as in vitro medical devices, nutritional supplements, biocidal products, cosmetics or chemicals. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.
Depending on the product, the provisions of more than one piece of legislation may be applicable, such as in the case of combination products. Dosing devices that contain a medicinal product (such as pre-filled syringes) are a concrete example of a combination product that must comply with the applicable requirements for both medicinal products and medical devices. Whether a product is classified as a medicinal product or medical device depends on its principal purpose and mechanism or mode of action.
Irrespective of the applicable legislation or classification, it is essential to carefully consider and investigate product concepts as a whole before launching a development project. Failure to do this can result in an excellent product that is the outcome of an expensive development process but one that lacks the correct route to the EU market and does not comply with all of the requirements applicable to it.
If your company does not have comprehensive expertise on the various regulations governing products and their classification, please turn to us for assistance. DRA’s experts are happy to help you! Read more about our services.