The EU Medical Devices Regulation (MDR) entered into force in May 2017 and will fully apply from 26 May 2020. While the existing medical device regime requirements will remain, the MDR imposes additional requirements and stricter standards on medical device manufacturers and broadens the scope of product coverage. This article answers important questions relating to the new regulation.
The existing EU legislation regulating medical devices will be replaced by the Medical Devices Regulation. The new regulation changes the European legal framework for medical devices, broadens the scope of the products and operators covered under this legislation and provides for increased responsibilities and obligations for manufacturers and notified bodies. It entered into force in May 2017 and will fully apply from 26 May 2020.
Patient treatment and research creates a wealth of data. Given that health data is sensitive, reaping the benefits of data-based medicine brings particular challenges when it comes to data protection requirements. EU data protection law is currently based on the Data Protection Directive, among other things. This directive will shortly be replaced by the General Data Protection Regulation, under which data concerning health is subject to increased protection.
The Medical Devices Regulation and the In Vitro Diagnostic Regulation, which the European Commission drafted following the Poly Implant Prothese breast implant scandal, were recently adopted. In particular, the Medical Devices Regulation strengthens market and post-market surveillance. The provisions require stricter assessment of product safety and clinical evaluations. In addition, the regulations cover previously unregulated aesthetic products.
The European Court of Justice recently ruled that the European Commission decision on the adequacy of the EU-US safe harbour framework is invalid. The ruling could have far-reaching consequences for clinical trial sponsors that have relied on the framework to justify the transfer of patients' personal data in the European Union to the United States.
The European Medicines Agency recently delivered an update on the implementation of its policy concerning the publication of clinical data. The policy enables interested third parties to access clinical reports and individual patient data submitted as part of a marketing authorisation or post-marketing authorisation for an existing centrally authorised medicinal product. Companies that fail to comply with the policy could be subject to remedial action.
The Council of the European Union recently reached a common position on two draft regulations intended to replace the EU Medical Devices Directive, the EU Active Implantable Medical Devices Directive and the EU In Vitro Diagnostic Medical Devices Directive. If the proposed regulations are adopted, they will lead to an overhaul of the regulations on medical devices and in vitro diagnostic medical devices.
Advanced therapy medicinal products (ATMPs) are a category of innovative products covering the main therapeutic areas of oncology and regenerative medicine. The EU ATMP Regulation attempts to implement an open market for ATMPs in which quality standards are consistently applied and adequately monitored.
The European Court of Justice recently found that mixtures of herbs containing synthetic cannabinoids cannot be regarded as medicinal products under EU Directive 2001/83/EC. The court stated that synthetic cannabinoids merely modify physiological functions with no beneficial effects on human health, and that they are consumed solely to induce a state of intoxication and as such are harmful to human health.
The General Court recently overruled a European Commission decision to refuse marketing authorisation for the drug Orphacol. This decision represents a setback for the European Commission in its attempts to limit the scope of the well-established medicinal use route for securing a marketing authorisation for a medicinal product. It is clear that the European Commission overreached itself in this case.
The president of the General Court of the European Court of Justice recently granted interim measures in favour of AbbVie and InterMune against the European Medicines Agency. The interim measures prevented the agency from disclosing to third parties certain clinical data that these companies had filed relating to authorised medicinal products before the companies' challenges to the agency's proposed actions had been fully examined by the court.