EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be as challenging as the industry expected it would be. Now, companies also have to establish compliance with the upcoming implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Device firms have been preparing for changes ever since the transition period from the Medical Device Directive (MDD) to MDR began in 2017. The anticipation was punctuated by the global pandemic, which forced a one-year delay in the regulation’s implementation to May 2021. Meanwhile, In-Vitro Device Regulation (IVDR) takes effect on May 26, 2022.
MDR lays down the rules on the sale of medical devices and their accessories in the European Union. The regulation also applies to clinical investigations pertaining to medical devices conducted by Member States.
As expected, MDR is making it harder for manufacturers to compete in Europe by requiring that all devices in the marketplace be resubmitted for compliance. There are grace periods depending on device type. Some manufacturers of Class I devices have until May 26, 2024, to comply fully.
Still, products that were compliant with MDD may not be up to par under MDR. Some items previously not considered medical devices (e.g., cosmetic contact lenses) must now comply with the regulation. The stakes are high for EU Medical Device Regulation non-compliance. Medical devices that fail to comply with MDR face removal from the EU marketplace.
As challenging as MDR and IVDR requirements are, the EU medical device market is too lucrative for manufacturers to ignore. MarketsandMarkets, a B2B research firm, forecasts the European device market as a whole to grow from $48.9 billion (U.S. dollars) in 2020 to $61.4 billion by 2025.
EU Medical Device Regulation Challenges
EU Medical Device Regulation documentation and other requirements are stricter than they were under MDD. Regulatory expectations are also higher today. For example, the 30-day timeframe for reporting serious incidents under MDD has become only 15 days under MDR. In the past, companies used to have up to 12 months to make any corrective actions. However, audit findings under EU MDR place emphasis on faster time to close on corrective actions. Furthermore, supporting data and documentation expectations are substantially greater.
Travel and other restrictions caused by the global pandemic aggravated the pressures for both manufacturers and regulators. The European Commission was forced to allow NBs to conduct remote audits of medical device companies and their suppliers. Fortunately, remote audits have for the most part been effective. A survey conducted by the European Association of Medical Device Notified Bodies (Team NB) revealed that 86.67% of survey participants said remote assessments identified about the same number of nonconformities as on-site audits.
In a position paper, Team NB expressed its concern over possible bottlenecks in the certification process. With MDR’s delayed implementation, many manufacturers postponed their application submissions, which are now likely to come all at once.
Furthermore, there are only 25 NBs handling MDR applications and six NBs handling IVDR applications (versus 51 and 21, respectively, under MDR). “These circumstances are inevitably leading to an extreme bottleneck in processing MDR and IVDR certifications,” according to the group. The backlog is likely to be at its worst around May 2024 when most MDD certificates expire. By then, firms with expired certificates will be scrambling to get new MDR certification.
The application process under MDR can be deceptively time-consuming. Some manufacturers with existing MDD certificates thought they had a lot of time to apply for their MDR certificates. They were wrong. They didn’t realize how lengthy the application process was under the new regulation. “Companies with an existing MDD certificate should pursue MDR certification ASAP,” advised MCRA, a CRO and advisory firm. “Review times are prolonged because of the ‘newness’ of the process.”
Manufacturers also discovered just how tough MDR’s equivalency standards are. For a company to claim that its product is the equivalent of an existing device, it must have access to data of the other company. This is proving to be an impossible task. Obviously, medical device companies are competitors. Not surprisingly, competitors do not willingly provide access to their data. Unfortunately, without a more realistic path to claim equivalency, most manufacturers might have to conduct their own clinical trials.
EU In-Vitro Device Regulation Challenges
Focus is now beginning to shift to IVDR, which took effect this month (May 2022). Just as with MDR submissions, Team NB is anticipating a backlog of IVDR applications due to the shortage of notified bodies. Not as many NBs have been trained on IVDR, therefore, fewer applications can be processed simultaneously.
The group is recommending remote initial and surveillance audits for IVD companies based on a documented risk-based approach. “The percentage of devices that will benefit from the grace period is estimated to be less than 10%,” according to the group’s position paper. Without remote initial audits and remote surveillance audits, the IVDR transition timeline will be unachievable, the group added.
Team NB noted the lack of harmonized standards and common specifications for the regulation’s implementation. It wants to be able to develop its own best practices in the absence of guidance from the Medical Device Coordination Group (MDCG). The group is responsible for oversight of NBs and standardization of market surveillance, among other things.
The European Database on Medical Devices (EUDAMED) is an important component of MDR and IVDR. The central database will monitor the safety and the quality of performance of medical devices. EUDAMED will increase transparency and serve as an exchange and reporting platform for medical device firms. Both the MDR and IVDR parts of EUDAMED will be mandatory when the entire EUDAMED system (modules) has been declared fully functional following an independent audit and a Commission notice.
The target live date for EUDAMED is May 2022, but as of this writing, it has not been declared fully functional.
The existing database (Eudamed2) was introduced in 2011. It also served as a central repository for market surveillance information, but it’s only accessible to the European Commission and national competent authorities. Medical device companies are unable to verify their own data or monitor how their data is presented.
One of the biggest differences between the two databases is that EUDAMED will be partially public. However, what that means exactly and how quickly the information can be available to the public are unclear.
EUDAMED consists of six modules: Actor Registration, Unique Device Identification (UDI) and Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Post-market Surveillance, and Market Surveillance.
All the modules are important, but most device firms are focusing on the UDI and Device Registration module. It’s crucial because it will contain tracking information for devices in the marketplace and identify safety issues.
In the United States, the FDA similarly requires UDI on device labels and packages, except where the rule provides for an exception or alternative. But the European Union requires more product data through a basic unique device identification (BUDI-DI). The BUDI part contains a device model’s product family identifier, while the DI part consists of the specific device unit identifier.
Just like with MDR and IVDR, the industry is wondering how EUDAMED will impact individual medical device firms. What’s the best way to meet MDR and IVDR requirements for EUDAMED? What would it be like to “interact” with the database and how will the information about product performance be shared? With EUDAMED’s pending launch, companies will soon find answers to those questions.
EQMS Opportunities for EU Medical Device Regulation Compliance
Now more than ever, manufacturers are realizing how exhaustive the documentation is under MDR and IVDR. In particular, there’s much ado about the required Summary of Safety and Clinical Performance (SSCP).
Manufacturers must provide this annual report throughout a medical device’s lifecycle. The document must have a section for healthcare professionals and another one for patients. The goal is to provide transparency by giving public access to information that used to be available only to regulators.
Manufacturers using paper-based quality processes or unconnected ERP, PLM, and other electronic systems will find SSCP and other requirements daunting. They will have to extract the information from voluminous records that will come from numerous sources. Managing individual quality processes and piles of documents are infinitely harder and more time-consuming under a manual system.
Under the new EU regulations, reliable data is critical to compliance. In order to establish and maintain sound, connected data, manufacturers need to unite all relevant areas of their enterprise. This is the best time for companies to make the switch to a fully automated quality management system. Using an integrated electronic quality management system (EQMS) is a fundamental way to ensure data integrity and data quality and to stay on top of MDR and IVDR documentation.
Tighter post-market surveillance under the new regulations requires a robust system that will enable timely submissions of manufacturer incident report (MIR). Information for MIR will come from the QMS, including clinical data, failure data, cause investigation, and market distribution information. Companies whose QMS platforms extend to their suppliers and contractors will be able to readily gather data from all sources.
MDR and IVDR also require more vigilance in updating and managing changes to a medical device, especially nonconformances. Given the time crunch in the new certification process, companies need to increase their efficiency in data collection and submission preparation. Automating routine tasks and streamlining workflows is the first step toward that. An EQMS can help companies with limited time and resources complete their submissions faster.
MDR and IVDR requirements call for cross-functional collaboration across a manufacturer’s operations. An EQMS makes collaborative work easier by connecting the different teams with each other and users with their tasks.
An EQMS also provides visibility into an organization’s records and processes, something NBs will be looking for during audits. Having a single repository for all quality and compliance documentation means NBs will go to only one place for everything they need. Most of all, an EQMS makes remote audits possible and ensures uninterrupted compliance.
FDA Versus EU Medical Device Regulation
With the advent of MDR and IVDR, European Union regulations are now a closer match with FDA requirements. Companies with effective QMS will find an unexpected opportunity in terms of managing FDA vis-à-vis EU compliance. With the right strategy, companies that are already compliant with the FDA’s Quality System Regulation and ISO 13485 can support EU submissions with less work.
There are a number of similarities in FDA and EU documentation requirements and approach. This is especially true in most aspects of device design, risk management, and manufacturing. FDA and MDR similarly call for documentation of verification and validation activities and design development and planning.
MDR requires a technical file, something that was left largely to a manufacturer’s discretion under MDD. The new regulation is more explicit about the importance of a technical file, which is meant to demonstrate that a device conforms to current regulations. In the U.S., a 510(k) premarket submission is the equivalent of a technical file. Companies with experience submitting to the FDA can use the same compliance framework for creating a technical file.
Unlike the old regulation, MDR requires a Clinical Evaluation Report (CER), a summary of data and literature review of the device, including any known hazards and risks. Manufacturers with the capability to submit premarket approval (PMA) annual reports to the FDA should be readily capable of generating a CER. While the details of the documents differ, the data needed will come from the same place: the QMS.
An effective and robust EQMS is the key to meeting both FDA and EU’s new regulations in the most efficient way. It will help companies leverage the same information about product design, manufacture, and safety despite any differences in formatting and reporting.
Now that almost a year has passed since MDR’s implementation, perhaps the worst part – prolonged, anxiety-ridden anticipation – is over. But it’s only the first leg of the EU compliance journey. Medical device firms have yet to discover what the imminent IVDR implementation will bring. They have yet to find out the impact of EUDAMED and stricter post-market surveillance.
However, one thing is certain. The European medical device market has become increasingly complex to enter. Manufacturers have equipped their enterprises with modern tools in order to keep up with the demands of the new regulations. They are leveraging an EQMS to consolidate their regulatory efforts and align their compliance goals with their business objectives.
Addressing the EU MDR and IVDR Certification Bottleneck
About the Author
Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.