One of the most important determinants in a successful launch strategy of medical devices is regulatory approval. Before a medical device can circulate on the European market, a medical device must bear a so-called “CE-mark”. The process of obtaining a CE-mark is often regarded as a rigorous, complicated, costly and lengthy procedure. This is mainly due to the fact that the CE-marking process is not transparent and the requirements to obtain a CE-mark can highly vary among the different types of medical devices. Preparation in an early development process is, therefore, essential to deal efficiently with this burden and warrant making the right legal choices. This is especially the case with the new medical device Regulations that will come into force (published in May 2017). These new Regulations are expected to bring substantial changes to the regulatory approval procedure, resulting in an increased burden in terms of time and costs.
Each medical device must bear a CE-mark before it can circulate on the European market
According to the European directives, a CE-mark is mandatory for medical devices placed on the European Union single market. The CE-mark indicates product’s compliance with EU legislation and thus, implicates that these devices meet EU safety, health and environmental protection requirements. By bearing a CE-mark, the medical device is considered as a product with sufficiently proven performance and safety for application in clinical practice and enables free marketability in the European Economic Area.
The current and new CE-marking procedure
Currently, medical device and in vitro diagnostic developers need to demonstrate that their medical device meets the requirements of respectively Directive 93/24/EEC and Directive 98/79/EC. These Directives describe the approaches that have to be followed in order to obtain the CE-mark. However, the regulatory landscape is about to change significantly. In 2020, Europe’s Medical Device Regulation (MDR) and in 2022 In Vitro Diagnostic Regulation (IVDR) will come fully into force, which will impact all medical device and in vitro medical device developers, respectively. Even though the final version has not been approved yet (expected May 2017), it is clear that Europe’s new MDR and IVDR will bring substantial changes. During the transition period, which is between the publication date of the MDR and IVDR and May 2020 (MDR) and May 2022 (IVDR), it is still possible to CE-mark devices according to the current legislation, i.e. the Medical Device (93/24/EEC) and In Vitro Diagnostic Directives (98/79/EC). Especially for start-ups it could be strategically beneficial to CE-mark their products according to the current legislation and switch to the new Regulations at a later stage.
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Xendo and ttopstart have collaborated to bring you “A comprehensive 6-steps route towards a cost-effective CE-mark”. This article provides more insight in which type of companies are advised to use the current Directives and will provide more clarity in the current, complicated, CE-marking procedure. Download the complete article to find more information about the legislation of medical devices in Europe and how to obtain a CE-mark:
- Identifying directives applicable to the device
- Verifying the device-specific requirements and harmonised standards
- Involvement and selection of a notified body
- Design and development of the medical device
- Technical documentation
- Affixation CE-mark