Following approval in March by the European Council and in April by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal of the European Union on 5th May 2017. Both Regulations entered into force on 26 May 2017, hence the new MDR rules will apply from 26 May 2020 and the IVDR rules from 26 May 2022.
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.
There are a number of changes being introduced by the new regulations, some of the most significant being:
The role of economic operators: Economic operators (the collective description for manufacturers, importers, distributors, suppliers, subcontractors and EU authorised 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.
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.
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.
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.
Quality management system: All manufacturers and their representatives must have an appropriate quality management system.
Person responsible for regulatory compliance: The regulations require that manufacturers and authorised representatives have permanently and at their disposal at least one person responsible for regulatory compliance. This isn’t necessarily an employee, but must be accessible to the organisation. 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.
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.
Unannounced audits: Notified bodies will be required to undertake unannounced audits of manufacturers and their authorised representatives. Notified bodies will have to provide schedules of unannounced audits to their national authorities.
Medical Device Coordination Group: The legislation includes the creation of a pan-EU expert committee, The Medical Device Coordination Group (MDCG). This will comprise representatives from the member states and will assist the Commission in the implementation and operation of the new legislation.
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.
EUDAMED database: The Commission will establish a centralised 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
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