Whether it is a food supplement, medical device or innovative medicinal product — the regulatory framework for development, testing/trial, market access, as well as the continuous maintenance of an approval once obtained is more or less extensive, depending on the product and the target group envisaged; however, in order to avoid complaints from the health authorities, knowledge of and compliance with these regulations is essential.

Challenge: Having a brilliant idea for an innovative product is usually the first milestone for a successful business model. The regulatory framework is determined by the healthcare sector in which the product is to be marketed. Knowing the legal requirements for the different sectors – cosmetics, medical devices/medical technology, pharmaceuticals – well helps to avoid stumbling blocks from the very beginning, as well as, for example, extensive reworking of approval-relevant studies, marketing concepts or advertising strategies. The regulatory classification of a product (based on the intended purpose), the early initiation of conformity assessment procedures and certifications (for medical devices in Classes I, IIa, IIb and III) or approval procedures (for drugs), including clinical trials and safety-relevant aspects (integrated safety/vigilance, pharmacovigilance), require foresighted planning and good preparation.

Outlook: Regulatory frameworks are subject to constant change and are subject to ever faster cycles due to the increasing globalisation and digitalisation of the health care system. The degree of complexity is also increasing – with corresponding effects on the best possible positioning of a product idea, the choice of the appropriate market environment and market access. Will a product be marketed as a medical device or approved as a drug? What requirements are derived from this for patient safety? What clinical trials are required for medical devices, how is drug safety ensured before and after the approval of advanced therapies (ATMP), orphan drugs or biopharmaceuticals? Experienced experts are needed to answer these questions pragmatically and individually.

Healthcare Shapers have experienced physicians and natural scientists who are experts in their respective fields and who are specialised in corresponding questions. They are familiar with the relevant legal framework and can ensure that companies and their products are operating in regulatory safe territory – an indispensable basis not only for the economic success of drugs and medical devices, but also for the best possible care of patients and users.