Guidance for EU MDR 2017/745 – Drug-Device combination products
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This guidance document is aimed at helping manufacturers of medical device products that are designed to be used in combination with substances that are considered pharmaceutical drugs or medicinal products (Drug-Device combination prodcuts), understand whether their product(s) will be regulated as a drug or regulated as a device, the classification and relevant regulations that apply to their products(s) and the implications of the new EU Medical Device Regulation 2017/745 on existing and new drug-device combination products.
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Description
This guidance document is aimed at helping manufacturers of medical device products that are designed to be used in combination with substances that are considered pharmaceutical drugs or medicinal products (Drug-Device combination products) understand whether their product(s) will be regulated as a drug or regulated as a device, the classification and relevant regulations that apply to their products(s) and the implications of the new EU Medical Device Regulation 2017/745 on existing and new drug-device combination products.
Our templates are developed with consultants who have over 20 years experience in the Medical Device industry and documentation that has been through successful audits.
Our consultants are available, should you need further assistance in completing the documentation.
