Essentials of European Medical Device Regulatory Affairs

• Borderline products are those for which it’s not clear whether they fall under the medical device's legislation or another piece of legislation • Due to the diverse interpretations that exist in determining the appropriate regulatory pathway for some medical products a working party on borderline and classification was established to facilitate a dialogue among regulators and industry to provide a forum to exchange opinions and reach consensus to ensure a consistent approach in product • The working party on borderline and classification publish the outcome of discussions in a manual which represents the views agreed by the regulators in the group, the views expressed in the manual are not legally binding, since the interpretation of Community law can only be provided by the European Court of Justice • It is also important to note that defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market The Working Party on Borderline and Classification

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Guidance https://ec.europa.eu/growth/sectors/medical-devices/current- directives/guidance_en

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