High-Risk Medical Devices: New Safety Requirements Issued

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High-Risk Medical Devices: New Safety Requirements Issued

The Medical Device Regulation (MDR) of the European Commission updated their regulation guidance recently regarding Class III and implantable devices. This new guidance is aimed at both manufacturers and anyone using the devices, whether in the sales or medical industry, as well as patients and end users themselves.

There are 4 classes of medical devices, ranging from Class I (low risk) to Class III (the highest risk). The new guidance requires manufacturers to assign a unique reference code to every device in their management systems. The goal is to increase transparency and offer full access to the product information. 

At this time only Class III devices are included in the new guidelines as well as implantable devices which are also Class III, or higher risk than the other classes. It is unclear whether future guidelines will cover devices in other classes.

MDR seeks to require the creation and validation as well as the publication of safety and clinical performance (SSCP) so that healthcare professionals as well as patients have full access to important information about the high-risk medical devices.

More about Device Identifiers

Each device will be assigned a unique numerical identifier which will stay the same for the lifetime of the device. The manufacturer also assigns a single registration number to allow for SSCP identification in the EU and EUDAMED.

The new template has an SSCP reference number from the manufacturer. Also, another section revised by the MDCG states that the summary can be associated with one medical device or with multiple devices using unique device identification (UDI-DIs).

The guidance was first written back in 2019 in order to assist notified bodies and manufacturers comply with MDR’s transparency provision. Since then it has been updated several times. The guide’s first revision kept all of the 2019 information intact but added the new paragraph relating to the medical device reference numbers. 

With this new update, the main change is that manufacturers must now issue reference numbers to batches of medical devices as well as individual ones to increase transparency and enable all users to have access to any information regarding these devices to enhance knowledge as well as safety.

Response to the Update

Debate continues regarding MDCG’s latest update and new requirements. Medtech trade groups in both Germany and France asked for an extension of the MDR transition period so a patient care collapse could hopefully be avoided. The members of Germany’s and France’s medtech trade groups makes up more than 50 percent of Europe’s medical device market.

These trade groups requested a 2-year extension for both implantable and Class III products as well as a 4-year delay for medical devices in other categories. 

In addition to this new requirement, there are other changes to the existing guidelines. Requiring a new safety of summary to be added is, according to the MDR, just one way of fulfilling objectives to ensure all users of these devices have the same access to information about them and increase transparency, which should ultimately result in safer use and reduce the risk of any negative impacts.

In Conclusion

The aim of these new regulations and guidelines is to increase transparency and knowledge for both medical professionals and patients using these devices to maximize safety in Class III devices as well as implantable medical devices. 

Manufacturers are now obliged to draw up a summary of product safety as well as the clinical performance of each device in this category. This should enhance safety as well as making clinical performance information available to every user of these devices.

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