Module 16 2022

02/09/2022

Safeguard Clause - Legal Basis

Required by Art. 95(10) of the EC Treaty ● All harmonisation measures must include a safeguard clause

Allows Member States to restrict the free movement of the products for the non economic reasons in Article 30 ● protection of health and life of humans ● the protection of industrial and commercial property

The Organisation for Professionals in Regulatory Affairs

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Elaborate procedures in Articles 94-99 MDR ● Where an NCA, based on data obtained by vigilance or market surveillance activities or on other information, has reason to believe that a device: – may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or – otherwise does not comply with the requirements laid down in this Regulation ● Can without delay require the manufacturer, authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action – to bring the device into compliance – to restrict the making available of the device on the market – to withdraw the device from the market, or to recall it, within a reasonable period ● NCA must notify the Commission, the other Member States and, where relevant, the notified body ● Commission may subject measures to scrutiny and take appropriate action ● Similar procedures existed under the Directives Safeguards and Medical Devices

The Organisation for Professionals in Regulatory Affairs

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