In September 2012, the European Commission released a Communication outlining its plan for the restructuring of the EU’s medical device regulatory framework. According to the Commission, the primary goals of the restructured framework would be: 1) to ensure a high level of protection of human health and safety; 2) to ensure the smooth functioning of the internal market; and 3) to provide a regulatory framework which is supportive for innovation and the competitiveness of the European medical device industry.[i]
Concurrently, the Commission also published a proposed regulation for medical devices and active implantable medical devices (2012/0266)[ii], and a separate proposed regulation for in vitro diagnostic medical devices (2012/0267)[iii]. The proposed regulations are expected to replace the three existing directives covering medical devices, active implantable medical devices and in vitro diagnostic medical devices. Further, when ratified, the proposed regulations will have the force of law throughout the EU and will not be subject to interpretation or transposition into national laws by individual EU member states.
Although specific aspects of the EU’s proposed medical device regulations are subject to further modification prior to their final ratification, the proposed regulations do provide some insight into changes likely to affect manufacturers, importers and distributors of medical devices once the new regulations take effect. While some of the anticipated changes will affect the approval and post-market surveillance of all medical devices, the largest impact is expected to fall on manufacturers of in-vitro diagnostic medical devices.
Each of the proposed medical device regulations includes a number of annexes which detail general health and safety requirements, classification rules, clinical evidence requirements, and the role of notified bodies. Some of the specific, anticipated changes from the current medical device directives include:
Extension of regulatory scope—Both 2012/0266 (medical devices and active implantable medical devices) and 2012/0267 (in vitro diagnostic medical devices) will extend the scope of medical and in vitro diagnostic devices currently regulated by the EU. Newly regulated products are expected to include implants for aesthetic purposes, genetic testing products, dedicated medical software, and some high-risk devices manufactured for use within a single health institution.
Implementation of classification structure for in vitro devices—In vitro diagnostic medical devices will now be subject to classification rules that allocate products to one of four risk classes, similar to the classification structure that already exists for medical devices in the EU. Notified body approval will be required for the majority of in vitro diagnostic devices, with the exception of those that pose a low risk to patients.
Reinforced regulations covering clinical investigations—2012/0267 will require manufacturers to provide a summary of safety and clinical performance in support of pre-market applications for in vitro diagnostic medical devices posing medium to high risk or high risk to patients, and to maintain post-market data for continuous assessment of potential safety risks.
Implementation of unique device identification requirements—Both 2012/0266 and 2012/0267 propose requirements regarding the use of unique device identification (UDI) mechanisms to increase traceability of devices through the supply chain, and to facilitate effective product recalls in the event of safety concerns.
Role of “qualified persons”—Manufacturers will be required to have within their organization at least one individual responsible for all aspects of regulatory compliance. This “qualified person” must possess the experience and/or skills appropriate to this task.
Expanded registration database of devices—Both regulations propose to expand the use of the European Databank on Medical Devices (Eudamed) to provide a centralized repository of information on approved medical devices for regulators and consumers. This change is expected to increase EU-wide access to product information, thereby increasing transparency and improving overall safety.
Increased regulation and oversight of notified bodies—Notified bodies will be subject to new minimum requirements to achieve and maintain designation, and more rigorous monitoring by national authorities through witnessed audits and other mechanisms.
Stronger post-market vigilance and surveillance—Notified bodies will be granted increased authority to conduct post-market product testing and sample checks, including unannounced factory inspections at manufacturing locations. Increased vigilance issues, reported field complaints or other product concerns may result in additional unannounced audits.
Greater coordination of regulatory efforts—The proposed regulations call for the formation of a medical device coordination group (MDCG) comprised of members representing national authorities. The goal of the MDCG is to facilitate coordination between EU member states of medical device regulation and surveillance, with scientific, technical and logistical support provided by the EU Commission.
Other changes—Both proposed regulations clarify key definitions and terms used to avoid confusion or misinterpretation. The regulations also clarify the legal responsibilities of medical device distributors and importers, as well as those who sell or market medical devices via the Internet.
Although the changes have yet to become compulsory, manufacturers can take important steps in advance of the EU’s final published regulations to prepare for the transition, thereby avoiding delays in bringing new and innovative medical devices to market.
[i] “Executive Summary of the Impact Assessment on the Revision of the Regulatory Framework for Medical Devices,” see Note 2 above.
[ii] “Proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009,” European Commission, 2012/2066 (COD), 26 September 2012. Web. 1 April 2014. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf.
[iii] “Proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices,” European Commission, 2012/2067 (COD), 26 September 2012. Web. 1 April 2014. http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf.