Guest post from Scott Avery
The changing landscape of European Union (EU) medical device regulations will have a profound impact on the medical device industry. Upcoming revisions to the regulatory framework within the EU will affect the ability for a medical device manufacturer to legally sell a medical device in the European market. Currently, the EU regulatory framework consists of the Medical Device Directive 92/42/EEC, the Active Implantable Medical Directive 90/385/EEC [5], the In vitro Diagnostic Device Directive 98/79/EC, and amendments in directive 2007/47/EC. In 2012, the European Commission devised a proposal to amend the regulatory framework and combine three of these directives into a single unified regulation[5]. By 2016, the Council of the European Union’s Permanent Representatives Committee endorsed a revised consolidated proposal titled “The Medical Device Regulation (MDR)” [5]. Following publication, the implementation of the MDR across the EU is expected to take place during 2017 and entail a three-year transition period [5].
For currently CE-marked products and the development of future devices, these new regulations are expected to provide improved patient care through increased levels of performance and safety as well as improved informed decision making for all stakeholders. With these new revisions, increased scope of regulations for what were previously considered non-medical devices, traceability, post market surveillance, and classification rules are worth examining closer.
Increased Scope of Regulations for Non-Medical Devices
Regulations will be extended to cover products that do not have an intended medical purpose, but contain similar characteristics and risk. These are products such as contact lenses, dental filling material, equipment for electromagnetic brain stimulation, and pregnancy tests [4]. Furthermore, common specifications will be adopted to the MDR and apply alongside the Harmonized Standards for Devices [4]. Common specifications will allow for harmonizing risk and safety, creating harmonized standards that currently do not exist or are not sufficient, and address health and safety concerns of the public [3][4].
Increased Traceability
Under the new MDR, medical device manufacturers must include a Unique Device Identifier (UDI) on device labels and packaging [3][4]. Each UDI will contain a device identifier (DI) that identifies manufacturer of the device and the production identifier (PI) that identifies the type of device unit and package [3][4]. The use of UDI on medical devices will allow traceability throughout the supply chain, effective and efficient collection of adverse event data, and increased coordination in product recalls [3][4]. In addition, UDI information will be registered into Eudamed, the centralized database for European Union Medical Devices [4]. Under the new MDR, Eudamed will undergo greater transparency. Notified bodies, the EU Commission, and the public will have access to greater comprehensive knowledge on medical devices placed on the EU market as data and information on safety and clinical performance will be uploaded on Eudamed directly [4].
Post-Market Surveillance
Medical device manufacturers are required to monitor products after they are CE-marked for sale on the EU market [3]. Post-market surveillance plans must be periodically updated and they must consider post-market clinical follow-up[4]. The MDR outlines specific provisions medical device manufacturers are responsible for monitoring [4]. The post-market clinical follow up will be used to analyze the safety and performance of the device [4]. Post-market surveillance plans for most medical device classes will be reported annually to notified bodies [4]. Also, unannounced audits are expected to become more prevalent and recurring.
Classification Rules and Notified Bodies
Medical devices will be classified as Class I, IIa, IIb, and III. Under the MDR, criteria have changed in which certain medical devices such as active implantables, surgical meshes, implants with certain substances and materials, and software are moving to Class III. These represent more stringent in regulations for those device types [4]. In addition, the MDR will introduce a new mechanism for scrutiny of conformity assessments [3][4]. Previously, notified bodies acted as “industry partners” and are now set to act as “policing bodies”. Medical device manufacturers will now be required to delegate a member or team responsible for all regulatory compliance. Notified bodies will work with this member or team to ensure certain certifications are granted to the medical device manufacturers.
Medical device manufacturers need to prepare for these new regulations. They will need to evaluate current products within their pipeline to assure compliance with the new regulations. Also, medical device manufacturers will need to cooperate with notified bodies to strategize future product launches. Medical device manufacturers will also need to evaluate from a business standpoint the effects of these new regulations. With the new MDR, launching products within the EU will likely take longer and open the door for product rejections. As a result, US-based medical device companies may reconsider their strategy toward conducting clinical evaluations, marketing, and selling products within the EU. Furthermore, per the International Trade Administration, there is a potential push to create a regulatory convergence that harmonizes the regulatory standards globally for all markets, which in the future can potentially add another layer of complexity for medical device manufacturers [1].
However, with the current state of these regulatory changes set to take place, once fully implemented, the Medical Device Regulations will greatly aid medical device professionals, patients, and regulatory bodies toward safer and more effective products.
References
[1] 2016 Top Markets Report Medical Devices [PDF]. (2016). International Trade Administration.
http://trade.gov/topmarkets/pdf/Medical_Devices_Executive_Summary.pdf
[2] Bernasconi, S. (2015). The European Medical Technology Industry – In Figures [PDF]. MedTech Europe.
[3] BSI Medical Devices – Medical Device Regulation FAQs [PDF]. (2017, February 1). BSI Group.
https://www.bsigroup.com/meddev/LocalFiles/en-GB/Documents/BSI-MD-MDR-FAQ-UK-EN.pdf
[4] REGULATION (EU) 2017/… OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of … on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC [PDF]. (2017, February). Council of the European Union.
http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf
[5] Revisions of Medical Device Directives – Growth – European Commission. (2017, June 03).
Retrieved March 06, 2017, from http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en