Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European Medical Device Regulation (MDR). At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of the European Union on 5th May, 2017.
With the passing of the new MDR, the previous regulations viz., the Active Implantable Medical Device Directive (90/385/EEC) as well as the Medical Device Directive has been totally replaced. The primary objective of the Revision of Medical Device Regulation is to ensure a regulatory framework that is sustainable, forceful, foreseeable and clear which is essential for ensuring that the level of safety is extremely high within the healthcare sector and at the same time fosters innovation
While these changes are certainly intended to benefit all the stakeholders, the implementation process is sure to experience certain bottlenecks. As a matter of fact, the healthcare sector also has the option of gradually incorporating the new MDR over a period of three years from when it will be fully in force. It means that the new MDR will actually come into effect from 2020 onwards. Nonetheless, it is imperative for medical device manufacturers to act now with a view to gain acceptance from stakeholders and ready their businesses to gear up to execute the necessary modifications within their business procedures.
Guidance to Medical Device Regulations in Europe
The Latest EU Medical Device Regulation would also impact notified bodies (NB) and the NBs within the next few months are expected to obtain designation. The spate of safety issues that cropped up in the past has had a substantial role in the formation of the new MDR, which implies that NBs on the whole are under tremendous pressure from their respective authorities to enhance the security levels of their medical device manufacturers. It is worth mentioning that issues related to capacity are already being faced by NBs where they have been experiencing a drop in the numbers within Europe. This issue is likely to witness an escalation considering the strict requirements that have been outlined by the new MDR.
NBs are specifically experiencing a dicey situation since they have already been experiencing a decline in their numbers however, it is predicted that there will be a marked increase for their services once the new MDR comes into effect. Following the re-designation of NBs as per the Regulation of Medical devices, it would not be possible for them to issue CE marks according to the earlier Directive, even in the period of transition. In such a scenario, manufacturers have to anticipate a long wait in order to make sure that their NB is in a position to assist them but they also need to be prepared to handle inspections that can occur without prior notice.
To highlight the key modifications that have been effected by the new MDR and to resolve these issues, the top five hurdles that device manufacturers will need to take care once the transition period of the new MDR is over, has been outlined as under:
Reclassification Lessons from a Notified Body
Special attention has to be paid to the new MDR classification rules outlined in Annex VIII which allows manufacturers to decide if the routes regarding conformity evaluation are applicable at present to their product portfolio. In case they are, they need to liaise with their NBs to ensure that every requirement is met within the time frame specified.
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All products are CE marked
Under the new regulation 2017/745, it is necessary that all products are CE marked. Therefore, it is essential to implement an effective plan to make sure that any products that will be placed in the market comply with the new Revision of MDR/IVDR(it is also applicable for all products that are currently under development).
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3. Reprocessing Single Use Device
A topic that has been largely deliberated while formulating the new MDR pertains to reprocessing single use devices.
As per the European Union Medical Device Regulation, it is now mandated that extending the use of single use devices and its reprocessing will only be allowed under national law but at the same time, it should also comply with the requirements as specified in the new MDR Article 17. Reprocessors, as a matter of fact are considered to be at par with manufacturers and hence should guarantee safety and performance levels that are equivalent to the initial single use device that corresponds with it.
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4. Technical Documentation
The Revision of Medical Devices will be very stringent when it comes to the necessary content required for technical documentation.
This is simply because the requirements for quality management systems are more detailed. Device manufacturers need to make sure that they are on the lookout for the new common specifications that will be outlined in the publication.
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The new MDR specifically outlines the requirements for clinical evidence that is equivalent to the risks that come with a medical device.
As an outcome, it would become necessary for medical device manufacturers to acquire more data through clinical studies. As a matter of fact, the new MDR makes it mandatory for device manufacturers to analyze all their clinical evaluation reports (CER), in case they have not been analyzed for the past couple of years. At the same time, they should also assure that post market surveillance (PMS) data is also incorporated within the CERs.
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Since the new Medical Device Regulation will be critically impacting several key procedures, it is essential that manufacturers be proactive and outline a realistic strategy that will help them to adhere with the new MDR.
Focusing on the proposed changes in silos or in a rather isolated manner would not be effective. Instead, device manufacturers should seek to delegate team members across functions within the business to take ownership of particular procedures and adaptations.
However, when manufacturers make sure that their products comply with the requirements, it can present several benefits too simply because the new MDR offers an opportunity to device manufacturers to carry out a product audit and jettison any products that are unnecessary or is of marginal use.
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