来源：MiniGene平台
Medical device manufacturers are currently faced with a three-year transition period before full application of the new European Medical Device Regulation (MDR) in 2020. The MDR will replace the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) in providing requirements and EU market access. There is a lot to do in this relatively short time-frame, including assessing all currently marketed medical device products against the new guidelines. This is a particularly onerous task with changes to the classification of some medical devices under the new MDR.
To comply with the regulations, it is essential for medical device manufacturers to identify which of their products will be affected by the new classifications and plan ahead to ensure that they remain compliant.
Where Will the Biggest Impact Be?
One of the biggest changes to classifications will occur in the orthopaedics space, mainly due to concerns around their long-term performance. Under a previous amendment to the MDD, all hip, knee, and shoulder joint replacements were reclassified from class IIb to class III. The MDR will add to this with all joints (ankles, elbows, toes, fingers, etc.) now being up-classified from IIb to class III devices. Ancillary components such as screws, wedges, plates, and instruments will remain classified as IIb, however, also in the orthopaedics space, many spinal implants will also be up-classified to class III. This means that every device will require detailed review of technical documentation by the appropriate Notified Body, which will lead to greater scrutiny in relation to the clinical data that is required to ensure patient safety.
New Rules to Consider
The new regulation will also introduce new rules, including specific requirements addressing the classification of software. The new classifications cover diagnostic, therapeutic, and physiological purposes, with the potential impact on patient safety and treatment determining the classification.
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Class III—software intended to provide information used to take decisions for diagnostic or therapeutic purposes that has the potential to cause death or an irreversible deterioration in health.
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Class IIb—software intended to provide information used to take decisions for diagnostic or therapeutic purposes that can cause the serious deterioration of a person’s health or a surgical intervention. Also covers software intended to monitor vital physiological parameters that could result in immediate danger to a patient.
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Class IIa—software intended to provide information used to take decisions for diagnostic or therapeutic purposes or to monitor physiological processes.
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Class I—all other software.
Another new rule involves the classification of active therapeutic devices. Those with an integrated or incorporated diagnostic function that significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, will now be classified as class III. Devices incorporating nanomaterial are addressed with a special new rule under the new MDR and they will now range from class I to class III, depending on the potential for internal exposure. Elsewhere, devices intended to administer medicinal products by inhalation, which are designed to treat potentially life-threatening conditions, will be up-classified from class IIa to IIb respectively. These are just some of the reclassifications. It will be important to study the new and amended classification rules for devices particular to your business.
Adopt Early to Stay A
head
For all manufacturers that intend to place or continue placing devices into the European market, understanding and complying with the new regulations is of critical importance. Companies are responsible for making sure that their products will meet the clinical data requirements and the safety and performance requirements as laid out in Annex I. While this is consistent in many ways with the current requirements, it may be challenging for many legacy devices to fully address without new data and/or robust clinical evaluations. At the outset of the implementation of the new regulations, manufacturers, Notified Bodies, and competent authorities will be learning together about the practical challenges of compiling, reviewing, and accepting sufficient data.
Start by compiling the compliance data and technical documentation for one or two of your products (maybe with different classification profiles) as an example for Notified Bodies to evaluate and accept or to identify any areas of weaknesses. Once you have calibrated your submission against the Notified Bodies’ expectations, it will be easier to confidently and efficiently implement changes across your wider legacy product portfolio before the new regulations come into full force.
There is no quick fix solution. Undertaking a gap analysis will enable you to evaluate how the changes to the criteria will affect your products and take your first steps towards compliance. Furthermore, it is likely that all technical documentation will need to be updated and all labeling will also need to be reviewed for compliance. The time pressure that this can place on a company should not be underestimated.
