Clinical Data For Medical Devices — Preparing For Increased Requirements In The EU

To market a medical device in the EU, a manufacturer must demonstrate that the device is safe, that it performs as intended, and that the risks associated with the use of the device are acceptable when weighed against the benefits to patients. Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. It may be based on a literature review and/or clinical experience and/or clinical investigations. While some medical devices do require data generated from a clinical investigation, it is often possible, for low- to medium-risk devices (Class I, IIa, and IIb), to rely on a literature review and/or clinical experience to support the device’s intended use.

The Medical Devices Directives (MDDs) form the foundation of Europe’s regulatory framework for medical devices. The relevant EU legislation addressing the clinical evaluation of medical devices is the Medical Device Directive 93/42/EEC, as amended (March 2010) and the Active Implantable Medical Device Directive 90/385/EEC, as amended (March 2010). This legislation was transposed into national law in all concerned countries.

European regulation of medical devices is undergoing significant revision. On September 26, 2012, the European Commission published a proposal for regulation of medical devices and a separate proposed regulation of IVD devices (which will not be discussed here). On  October 22, 2013, the European Parliament voted to accept 347 amendments to the Commission’s Medical Devices Regulation Proposal. The formal legislative vote was held on April 2, 2014, which resulted in the Parliament’s adoption of the amended proposal. This action closed the first reading of the ordinary legislature procedure. On November 5, 2014, the Committee on the Environment, Public Health and Food Security of the European Parliament mandated the rapporteurs to enter into negotiations with the Council of the EU aiming to reach an agreement on these proposals.

This white paper focuses on the regulatory changes set to erode the traditional differences between medical device and pharmaceutical clinical studies. A significant aspect of The Medical Devices Regulation Proposal is that it represents a bid to raise the regulatory bar on clinical evidence requirements, exposed as inadequate by the scandal of defective breast implants produced by the French Poly Implant Prothèse (PIP).