To heighten quality, safety and transparency as well as reduce risk with medical devices, the European Parliament and the Council of the European Union (EU) developed the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). When the regulatory upgrade was put into motion in 2017, the medical device industry has been keeping a close eye on its progress.
Along the way, medical device companies started voicing concerns about certain aspects of MDR, such as:
Still, in ready-or-not fashion, the EU was determined to begin enforcing the MDR on May 26, 2020 — then COVID-19 happened.
The all-hands effort to develop tests, treatments and ultimately a vaccine is keeping regulatory agencies busy. Therefore, governing bodies agreed to push MDR out a year. However, EU officials advised device manufacturers not to take their foot off the gas because the new regulations will happen.1
One aspect of MDR that medtech companies can count on is an obligation to have more things in writing. That said, a new document added to the lineup is a summary of safety and clinical performance (SSCP). This an annual report manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.
In a nutshell, the MDR states that with implantable and class III devices, other than custom-made or investigational devices, the manufacturer shall draft a summary of safety and clinical performance.2 Class III and implantable devices are expected to have clinical data derived from clinical investigations that were conducted under the supervision of a sponsor.
The guidance surrounding the SSCP says the document is intended to:
The SSCP needs to be sourced entirely from the device’s technical documentation (TD). This means the document can be extensive depending on the type of device and its intended purpose. According to the guidelines in Article 32, the SSCP needs to include at least the following elements:
There are several guidelines for the SSCP that device manufacturers need to follow. These guidelines mostly apply to formatting and readability. The SSCP should be:3
When the manufacturer completes the SSCP, the NB validates that the document is complete and adheres to the all of the guidelines. The NB then uploads the document to the European Database on Medical Devices (EUDAMED). Only the notified body is authorized to manage the SSCPs in EUDAMED.
At this point, the manufacturer must verify that the SSCP and all translations have been uploaded before placing a device on the EU market.
Modernizing your quality management system and processes gives you the confidence to sufficiently prepare for and comply with the requirements of EU MDR. The MasterControl Platform enables you to more easily comply with all the new and existing documentation requirements in the updated regulation.
To learn more and prepare for MDR/IVDR, download MasterControl’s exclusive industry brief: “EU MDR: How to Prepare for the Upcoming Changes in Regulation”
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