The MedTech sector has recently undergone significant changes, most notably the EU transition from the Medical Device Directive (MDD) to the Medical Device Regulation (EU MDR 2017/45). Not surprisingly, this transition has had a major impact on the industry, as manufacturers have had to adjust their processes and products to meet the new requirements.
The MDR includes more stringent requirements for device design, clinical evaluation, and reporting. It also requires more transparency and traceability in the supply chain and introduces new labelling requirements, and there’s a requirement for manufacturers to provide more information regarding the design, performance, and safety of their products, as well as provide evidence that their products are fit for purpose.
There is of course the continuing requirement for manufacturers to use designated Notified Bodies for product certification (for all products other than Class I devices). This has been a challenge for many manufacturers, as there is still a shortage of Notified Bodies that can perform conformity assessment under the EU MDR.
Furthermore, manufacturers must also demonstrate conformity with the MDR for the duration of their product lifecycle. This means that manufacturers must continue to comply with more MDR requirements throughout the life of their product, especially vigilance and surveillance after placing a product on the market.
The MDR also introduces new Unique Device Identification (UDI) coding. This means that manufacturers must now provide more detailed product information to patients and healthcare professionals, as well as ensure that their products are traceable throughout the supply chain.
Overall, the transition from MDD to MDR has been and still is a challenging one for the MedTech sector. Manufacturers have had to adjust their processes and products to meet the uplift in requirements and have face difficulties with the strained capacity of Notified Bodies. However, despite these challenges, the changes made by the MDR do serve to improve the safety and transparency of medical devices and provide more detailed product information to patients and healthcare professionals. Ultimately, all of these changes are designed to prevent the historical recurrence of device failures that resulted in patients being harmed.
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