6 Areas That Need Your Attention Before Your Next EU MDR Notified Body Audit

The European Medical Device Regulation (2017/745) went into effect on May 26, 2021 and there’s still a lot to focus on.

If you have legacy devices that will require EU MDR registration between now and 2024, there are some things that you need to focus on to ensure your product remains on the European market.

1 – Get your existing clinical evaluation reports in shape.

MEDDEV 2.7/1 rev 4 expanded the requirements for clinical data and the MDR reinforces this requirement. Manufacturers of medical devices must plan, conduct, and document a clinical evaluation to demonstrate conformity with the relevant general safety and performance requirements found in Annex 1. This evaluation and the related documentation must be updated with postmarket clinical data throughout the life cycle of the device. You will want to review your CERs very carefully to ensure compliance with the new requirements.

Key questions to consider: How will you identify and address the expanded requirements related to postmarket surveillance, the process of clinical evaluation, and the necessary clinical evaluations? How will you address the stronger linkage between clinical evaluation and risk management? How will you plan to evaluate the device’s use in the field and the benefit-risk ratio on a continuous basis?

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2 – Reexamine equivalency claims during your CER reviews.

Companies selling devices compliant with MDD 93/42/EEC have long used existing scientific literature and equivalent device statements in their CERs. The purpose of doing so was to avoid having to conduct redundant pre- or postmarket clinical studies that prove safety and performance. However, the definition of equivalent was not specified in the Medical Devices Directive (93/42/EEC), leaving much room for interpretation.

Under the MDR, there is now clear text stating that clinical data being leveraged by an organization must be for an equivalent or similar device. While the MDR does not define parameters for determining equivalence, the guidance document MEDDEV 2.7/1 rev 4 has distinctly identified criteria for evaluation of an equivalent device to be used as clinical evidence.

Key questions to consider: If you are in the process of reviewing CERs for devices that already have CE Marking, have you taken a close look at “equivalent” device data used in literature reviews to ensure they meet the new tighter definition?

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3 – Closely examine the current state of the art.

In the European MDR and associated MEDDEV 2.7/1 rev 4, you are expected to demonstrate that you have conducted a thorough analysis of the current state of the art. Notified Bodies are increasingly looking to see that you have performed an in-depth assessment of alternative treatment methods for the same indications thus, you can expect more scrutiny during your next surveillance audit.

You are required to take state of the art into account when assessing the risk acceptability of your devices, adopting risk control measures, and determining the clinical benefit of your devices. As such, state of the art is critical in defining the benefit-risk ratio of the device, and you need to take it seriously in your clinical evaluation report (CER). If your device has been on the market for decades and there are two devices that are technically superior and present lower risk than yours, they lower the benefit of your device and increase the risk side of your benefit-risk equation.

Key question to consider: Have you performed a thorough assessment of alternative treatment methods for the same indications?

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4 – Get your act together on PSUR and PMSR.

The MDR places a larger emphasis on postmarket activities. It requires organizations to have a postmarket surveillance (PMS) system based on a plan. This plan and PMS documentation must be part of the technical documentation for the device ΓÇô a significant difference from previous requirements.

Another significant change is that PMS is viewed as a proactive process in the MDR that requires medical device manufacturers to be fully aware of their products in the market. As part of being proactive, the regulations emphasize trend reporting requirements that must be actively monitored and reviewed. Manufacturers must prepare a Periodic Safety Update Report (PSUR) for each Class IIa, Class IIb, and Class III device that is submitted to the Notified Body for review. Manufacturers will eventually submit vigilance and postmarket surveillance reports to the EUDAMED database.

Key questions to consider: How will you assess your current postmarket activities to understand the impact of the significant new requirements related to postmarket surveillance? How will you redesign your complaint-handling processes to make them more proactive? How will you ensure that PMS information is tied back into risk management, clinical evaluation, and design changes for the product?

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5 – Appoint Your Person Responsible for Regulatory Compliance (PRRC).

The MDR requires the appointment of a PRRC. The PRRC (see this post) does not replace the European Authorized Representative (EC Rep) but they are symbiotic. The EC Rep must be located in Europe and meet requisite qualifications that are well defined in the MDD/IVDD and MDR/IVDR. All companies need a PRRC even manufacturers of low-risk devices. The PRRC has far more responsibilities than the EC Rep as assigned in Section 3, Chapter 1, Article 15 of the MDR. Here’s an abbreviated list of PRRC responsibilities:

• Check conformity of devices with QMS procedures before they are released.
• Make sure all technical documentation and Declarations of Conformity are up to date.
• Ensure all postmarket surveillance and reporting obligations are met.

MDR Article 15 offers some relief to smaller companies. Basically, you are exempt from having a PRRC on staff (you still need one) if, at the close of your most recent accounting period, you had fewer than 50 full-time global employees and under 10 million Euros in sales/turnover (global revenue, not just EU).

Key questions to consider: If you personally meet the qualifications to be a PRRC, will you take on this role yourself or outsource it? Will the PRRC role impact your existing AR, distributor, or importer agreements?

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6 – Update agreements with your EU importers and distributors.

The EU MDR requires the importer and distributor to verify that the manufacturer and device meet the European MDR requirements before the device is imported or sold into the European Union. Specifically, Articles 13 and 14 of the EU MDR reinforce (and add specificity to) the need for supply chain economic operators to take on more verification responsibilities such as:

• Verifying that your device actually has CE Marking.
• Making sure you have an Authorized Representative.
• Ensuring that the device is labeled properly and has an IFU.
• Making sure the device meets EU UDI requirements.

Technically, the importer requirements are already mandated in Section 3.3 of the Blue Guide on CE Marking published in 2016, but they are sure to get more scrutiny from Notified Bodies since Article 13 of the MDR greatly elevated the role of the importer. Can you ask your distributor to be your importer? Maybe. Here’s a good Know More on that.

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Get your game plan together.

If you’re feeling a bit overwhelmed by all the tasks you need to complete to get ready for an MDR audit, you’re not alone. To get on track quickly, consider our MDR overview training class or our more advanced MDR auditor class. Because technical documentation is also such as critical component of MDR compliance, also consider our in-depth CER training. We are also ready to assist you with all aspects of MDR compliance.