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As delivery system technology and medical devices continue to develop, the combination of drug-device and device-drug modalities are rapidly increasing and the distinction between the modalities is becoming blurred. In some situations, it is difficult to determine as to which regulations, submission procedure and pathway to market must be followed. Correct classification is a key as in the European Union, combination products are regulated as either medicinal products or medical devices.
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.
Medtech and Pharmaceutical/biotech companies increasingly must stay informed about implications of the EU MDR. EU MDR came into full effect on 26 May 2021 and will encompass all integral, single-use combination products regulated as medicinal products. In the European Union, combination products are regulated as either medicinal products or medical devices.
For marketed CE Marked devices under MDD and AIMDD whether standalone or co-packaged with medicinal products, these devices must also conform to MDR.
“Substantial” device design changes of already marketed single integral combination products will require NB opinion. To ensure that operations conform with the EU MDR, pharmaceutical/biotech companies must have compliant design controls, integrated risk-management procedures, and improved processes for complaint handling. Companies must have closer oversight of their device and component manufacturers. Because compliance is an ongoing activity that lasts throughout a device’s product lifecycle, businesses are encouraged to incorporate device compliance processes into their operations as soon as possible. Given overdemand for notified bodies in the regulatory arena, an early start can make the difference between a product market freeze and full compliance for market access.