Andrew love explores how the ‘most significant changes to medical device legislation in decades’ will impact their supply and implementation.
Note: The contents of this article do not constitute as legal advice.
New rules from the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - will apply from May 2020. Just two years later, the mandates will activate from the In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746.
Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents.
Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.
Changes
There are a number of changes being introduced by the new regulations, some of the most significant being:
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The role of economic operators: Economic operators (the collective description for manufacturers, importers, distributors, suppliers, subcontractors and EU authorized representatives) carry the ultimate responsibility for conformity to regulations. The legislation outlines the general obligations of each or these parties, explaining both what they need to do and how they need to do it.
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The scope and classification of products: Whilst the classification system (Class III, Class IIa, Class IIb and Class I) is retained, some rules have been tightened.
Some industry commentators anticipate this could result in some devices moving to higher classes of product. Moreover, a number of types of products that were previously exempt from the regulations are now included in scope.
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Technical files, common specifications, clinical evidence, conformity assessments and product labelling: Additional requirements have been included to each of these aspects of product registration and approval. These may require further product information or testing to be provided to support approval.
Transitioning arrangements for existing products or products currently undergoing conformity assessment are being clarified, but some industry experts are concerned that these new requirements could require all products to be registered as they transition to the new legislation.
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Vigilance and post-market surveillance: The regulations introduce further requirements for vigilance and post-market surveillance undertaken by both the Economic Operators and the National Authorities.
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Quality management system: All manufacturers and their representatives must have an appropriate quality management system.
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Person responsible for regulatory compliance: The regulations require that manufacturers and authorized representatives have permanently, and at their disposal, at least one person responsible for regulatory compliance. This is not necessarily an employee, but must be accessible to the organization.
The person is responsible for ensuring the conformity of devices are checked prior to release including that technical documents and certificates of conformity are accurate.
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Notified body re-designation: The legislation includes a series of requirements for notified bodies who will be required to be re-designated as part of the regulation.
It is targeted to have this complete towards the end of 2018.
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Unannounced audits: Notified bodies will be required to undertake unannounced audits of manufacturers and their authorized representatives. Notified bodies will have to provide schedules of unannounced audits to their national authorities.
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Medical Device Coordination Group: The legislation includes the creation of a pan-EU expert committee, The Medical Device Coordination Group (MDCG). This will comprise of representatives from the member states and will assist the Commission in the implementation and operation of the new legislation.
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Unique device identification (UDI): UDIs will be introduced on all medical devices. They will be placed on the label of the device, implant cards for Class III devices, and in the case of re-useable devices, potentially on the device as well. These UDIs will be used to provide traceability of use of devices.
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EUDAMED database: The Commission will establish a centralized EU database for the storage of information on medical devices (EUDAMED). This will facilitate the communication of both pre- and post-approval product information between economic operators, the Commission, member states and in some cases healthcare professionals and the public. It is targeted to have this database available towards the end of 2018.
As can be seen from the above changes, the requirements for the new legislation are varied, impacting the majority of parties involved in the supply and governance of medical devices to the EU market across the entire lifecycle of each device.
The legislation is in force now so companies need to act to define their strategies for transition.
Andrew Love's next posts will examine strategies to address the new EU MD and IVD Regulations and how to adapt Quality Management Systems (QMS).