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:

1. The lack of guidances.
2. Too few qualified Notified Bodies (NB).
3. Unrealistic deadlines due to Nos. 1 and 2.

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

MDR Will Require Additional Documentation

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.

What is the SSCP?

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:

• Provide information about the device’s safety and performance. This includes the clinical benefits and the success rate for achieving the intended outcomes.
• Inform patients of residual risks and side effects with implantable devices intended to be used directly by the patient.
• Provide health care workers with a summary of the clinical evaluation results of all the available clinical data related to the device.

What Information Should the SSCP Contain?

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:

• The identification of the device and the manufacturer. This includes: the Unique Device Indentifier (UDI) and, if issued, the Single Registration Number (SRN).
• Description of the device. This includes references to any previous generation(s) or variants of the device, a description of the differences and a description of any accessories intended to be used in combination with the device.
• The device’s intended purpose, indications, contraindications and target populations.
• Possible diagnostic or therapeutic alternatives to the device.
• A reference to any harmonized standards and common specifications (CS).
• The summary of the clinical evaluation as referred to in Annex XIV and relevant information on postmarket clinical follow-up.
• Suggested profile and training for users.
• Information on any residual risks and any undesirable effects, warnings and precautions.
• The device’s revision history.

What SSCP Tasks Are Completed by the Sponsor and its Notified Body?

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

• Written in a way that is understandable by the intended user (e.g., health care professionals and patients). This means there should be separate sections written specifically to the readers’ level of knowledge.
• Organized and clear. Avoid jargon and abbreviations. The first instance of acronyms need to include the full phrase they are replacing.
• Translated into all the languages accepted in the Member States where manufactures intend to sell the device. There must be a separate document for each language.

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.

Achieve MDR Compliance With Digital QMS

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”

References

1. “MDR delay official as industry calls to push back IVDR,” Michael Mezher, RAPS, April 24, 2020. https://www.raps.org/news-and-articles/news-articles/2020/4/mdr-delay-moves-forward-as-industry-calls-to-push
2. “MDR – Article 32 – Summary of Safety and Clinical Performance,” Medical Device Regulation, https://www.medical-device-regulation.eu/2019/07/10/mdr-article-32-summary-of-safety-and-clinical-performance/#:~:text=1.&text=The%20summary%20of%20safety%20and,to%20the%20public%20via%20Eudamed.
3. “New MDCG guidance on summary of safety and clinical performance,” Hogan Lovells, September 30, 2019 https://www.engage.hoganlovells.com/knowledgeservices/news/new-mdcg-guidance-on-summary-of-safety-and-clinical-performance-under-the-medical-devices-regulation-mdr#:~:text=Article%2032%20of%20the%20MDR,shall%20draw%20up%20a%20SSCP.