Just one year until the MDR takes effect
On 25 May 2017, the medical devices industry was subjected to an extensive array of new regulatory conditions with the publication of Regulation (EU) 2017/745, the MDR Regulation. Even now that two thirds of the three-year transitional period until the MDR takes effect on 26 May 2020 has expired, many questions remain unanswered. And previously published “corrigenda” to the text of the MDR do little to clarify the key questions surrounding the Regulation.
The manufacturers alone are not in control: they are dependent on reliable implementation of the structures provided for in the MDR so as to ensure that they themselves and their products will be MDR-compliant. However, there continues to be a major snag in this regard.
So far, the European Commission has accredited exactly eleven notified bodies in accordance with the MDR (as of Febuary 2020). At the same time, the MDR’s new classification rules mean that a much larger number of products than before will have to undergo conformity assessment procedures, which have to be overseen by the notified bodies. For these new products, 26 May 2020 is a hard deadline. Even the extended period known as the “sell-out rule,” under which products conforming with the MDD may remain on the market even after the MDR takes effect, does not apply in this case. As a result, it is already clear for many manufacturers that successful MDR certification on the effective date will not be possible for some products.
Strategies for manufacturers
Manufacturers have no control over external circumstances, particularly the question of how quickly a relationship can be established with an MDR-accredited notified body. If they have not done so already, it is therefore important for manufacturers to use the last twelve months remaining before the Regulation takes effect as effectively as possible and consider the aspect of product life cycle, which is so important for the MDR. Are products or product families correctly classified in accordance with the MDR? Can sufficient clinical data be generated? Are the processes for clinical assessments and trials regulated in greater detail under the MDR than was the case before? How far has planning progressed for the UDI and label requirements which must be adhered to when the MDR goes into effect?
Also important: implementation of a risk management or, at least reviewing the existing risk management system, in accordance with the MDR’s requirements. Right after Article 10(1) of the MDR, which establishes the central duty for manufacturers: ensuring that the medical devices they manufacture and market are MDR-compliant, the requirement for a risk management system can be found in Article 10(2) of the MDR. Manufacturers should use the remainder of the transitional period to adapt their quality management system so that it contains clear risk management processes which conform to the MDR, and to ensure that the planning, implementation and assessment of this system is documented and supported by appropriate evidence. Quality assurance for products can only be accomplished by working together with suppliers and distribution partners. The MDR’s explicitly stated objective, minimizing risks to patients and users in connection with medical devices, requires manufacturers to optimize their supplier management as well as working more closely with distributors. It is necessary to be able to track products through their entire life cycle, back along the supply chain to the development service provider and all the way to the end user on the other side, so that a close contractual arrangement is required for the interaction of economic operators. Accordingly, when manufacturers conduct reviews of their quality management systems, they should consider how to ensure adequate assessment of their suppliers and distribution partners, as well as analyzing any standard contracts which may exist, particularly quality assurance agreements, for provisions requiring the contracting parties to cooperation and provide information, in light of the need to ensure that products can be tracked.
Once the MDR takes effect, manufacturers (with the exception of small and micro-sized enterprises) will be required in accordance with Article 15 of the MDR to have at least one person in their organization who will be responsible for compliance with regulations. Accordingly, it is necessary to examine before the Regulation takes effect whether such a position can be assigned internally, whether there is a need for training and whether an external request for proposals should be initiated.
Conclusion
Ultimately, manufacturers would be well-advised to use the remainder of the transitional period pragmatically in order to ensure implementation of the requirements formulated by the MDR. As of now, it remains an open question how individual requirements will ultimately be “experienced” in practice, in terms of their details and dimensions, and how specific clauses will be “interpreted” by notified bodies and by the authorities. Accordingly, it is advisable for manufacturers to be able to furnish solid explanations for the course they take and to document their chosen approach in a structured and comprehensible fashion.
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