The regulatory landscape for medical device manufacturers in the EU has changed significantly with the introduction of new regulations. Navigating these requirements can be challenging, but with the right guidance, compliance and market success are within reach. At Profil, we have a deep understanding of these challenges, not only from our own experience with medical devices but also through our extensive work assisting clients in clinical trials.
In this guide, we will share the key steps you need to take to ensure your products comply with the new EU regulations and successfully reach the market. By following these seven essential steps, you can navigate the regulatory landscape with confidence, backed by insights from Profil’s seasoned experts who have guided numerous clients through similar journeys.
The first step is to determine whether your product qualifies as a medical device under EU regulations. This step is crucial because your product's intended purpose, as defined by the manufacturer, dictates whether it falls under medical device regulations. Keep in mind that the focus here is not on what the product could do, but rather what it is intended to do. This intended purpose must be clearly stated in the technical documentation.
Once your product is identified as a medical device and you plan to market it within the EU, both European and national laws will apply. European law takes precedence over national laws, and EU regulations are directly enforceable across all member states. The most critical of these is Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2023/607, which covers transitional provisions. These are fully (directly) binding for all manufacturers. Be sure to keep your technical documentation up to date with all applicable regulations.
Alongside European law, it is essential to consider national laws as well. This becomes especially important when national legislation introduces entirely separate regulations or when it implements or extends European directives.
Once you have identified the relevant laws, the next step is to meet the specific regulatory requirements. Begin by classifying your product according to its risk level as outlined in MDR Article 51 (Class I, IIa, IIb, or III). This classification will determine the conformity assessment procedure you need to select, as detailed in MDR Article 52. The aim of this procedure is to verify that your product complies with the basic safety and performance requirements mandated by the MDR. Upon successful assessment, you can then declare the product's conformity with a declaration of conformity.
The most commonly used conformity assessment procedures in connection with a certified quality management system are:
|
Risk class |
Conformity assessment according |
Reference, |
|
III |
Annex IX |
Article 52 (3) |
|
IIb |
Annex IX chapter I and III, as well as evaluation of the technical documentation |
Article 52 (4) |
|
IIa |
Annex IX chapter I and III, as well as evaluation of the technical documentation |
Article 52 (6) |
|
I |
In general, no assessment by a notified body or limited participation |
Article 52 (7) |
In addition to selecting the appropriate conformity assessment procedure, it is crucial to identify and meet any further requirements based on Annex I of the MDR. This involves checking which standards, common specifications, and guidelines apply to your product and ensuring these are properly documented and adhered to.
A robust Quality Management System (QMS) is essential for placing your medical device on the market. The MDR outlines the minimum requirements for a QMS in Article 10 and Annex IX. For Class IIa, IIb, and III devices, your QMS must be certified by a Notified Body, which confirms that your system meets regulatory standards and effectively manages product risks. While Class I devices also require a QMS, certification by a Notified Body is generally not necessary.
Your QMS should integrate the basic safety and performance requirements from Annex I of the MDR, along with any relevant standards and guidelines, ensuring that your product is fully compliant and ready for conformity assessment.
After identifying the legal requirements for your product and organization, the next crucial step is to ensure that these requirements are thoroughly and verifiably met. This is where harmonized standards and other normative specifications play a key role. Standards are your best friends when it comes to demonstrating compliance.
Standards are powerful tools that help manufacturers prove that their medical devices comply with legal regulations. These standards represent the current state of the art in the industry. Although their application is technically voluntary, they are widely recognized and accepted worldwide, making them incredibly useful for proving conformity through standardized processes. Developed by independent (non-governmental) organizations, these standards provide a framework for ensuring quality and safety.
When these standards are harmonized with European regulations, they gain official recognition by public authorities. Adhering to these harmonized standards offers manufacturers a presumption of conformity with EU regulations, making the regulatory process smoother and more predictable. Whenever a harmonized standard exists for a requirement, it should be the preferred choice.
In cases where no appropriate standards exist, or where the existing standards are insufficient to address specific public health concerns, the European Commission may introduce common specifications (CS) after consulting the Medical Devices Coordination Group (MDCG), as outlined in MDR Article 9(1).
Although many guidelines and related documents are not legally binding, they provide valuable insights into the interpretation of laws, regulations, and standards. For example, MDCG documents serve as practical aids for implementing the MDR. While not legally binding, these documents are often regarded as “quasi-binding” by notified bodies due to their influence on regulatory practices.
Once you have identified the relevant standards and regulations, it’s time to put them into action. This may involve converting requirements into internal processes, establishing detailed procedural instructions, or ensuring that the product design itself meets all necessary criteria.
Clinical evaluation is an ongoing, systematic process designed to verify the safety and performance of your medical device, as specified in MDR Article 2(44). This process involves generating, collecting, analyzing, and evaluating clinical data to ensure the device delivers its intended clinical benefits. The evaluation process must be documented and carried out at regular intervals, with all results recorded in the technical documentation. If needed, clinical evaluations should be supplemented by clinical trials, with all relevant documents stored within the technical files.
The Unique Device Identifier (UDI) system, mandated by MDR Article 27 and Annex VI, Part C, is essential for tracking medical devices from manufacturer to end-user. The UDI ensures that devices can be quickly and easily identified and traced throughout their lifecycle.
All evidence gathered—from compliance with standards to clinical evaluations—must be compiled into comprehensive technical documentation. This documentation is crucial for the conformity assessment and eventual approval of your medical device, as regulated by Annex II of the MDR.
Under MDR Article 15, manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC ensures that:
Moreover, MDR Article 84 and Annex III require that the technical documentation includes a post-market surveillance plan, ensuring ongoing compliance after the product is on the market.
Once all necessary requirements have been met, there are a few final steps to complete before your prod-uct can be launched on the market.
The first step is to issue a declaration of conformity. This is where the manufacturer takes full responsibil-ity, certifying that the product complies with all applicable legal requirements. According to MDR Article 56, if the product has undergone assessment by a notified body, the corresponding certificate of conformity must be included. This declaration becomes a critical part of the technical documentation.
Next, manufacturers are required to register with the European Database for Medical Devices (EUDAMED) as stipulated by MDR Article 31. This registration ensures that your company is recognized within the EU system as an official manufacturer of medical devices.
In addition to registering as a manufacturer, you must also register your products in the EUDAMED data-base as outlined in MDR Article 29. This step is essential for tracking and ensuring transparency before your product can be placed on the market.
However, your responsibility does not end once the product is on the market. Continuous vigilance is key to ensuring that your product remains safe and effective throughout its lifecycle.
After your product is introduced to the market, it is crucial to monitor its performance continuously. Post-market surveillance (PMS) is a proactive and systematic process designed to collect and analyze data on the product's use. This ongoing monitoring helps identify any potential issues early on, allowing you to implement corrective and preventive actions (CAPA) to maintain the highest standards of safety and per-formance.
Vigilance processes go hand-in-hand with post-market surveillance, but they are more reactive in nature. Under the MDR, you must report any serious incidents or safety concerns to the appropriate authorities. This process ensures that any risks associated with the product are addressed promptly and effectively, protecting both users and the reputation of your product.
The regulatory environment is ever-evolving, and staying informed about updates and changes is crucial. Regularly reviewing and adapting your compliance strategies will ensure that your product continues to meet all regulatory requirements. Being proactive about these updates will help you avoid any compliance issues and keep your product safely on the market.
Navigating the new EU regulations for medical devices might initially seem daunting, but with the right approach, you can manage the process with confidence. By staying informed, organized, and vigilant, you can successfully bring your products to market and ensure their ongoing compliance throughout their lifecycle. The key is to approach each step with diligence and a commitment to maintaining the highest standards of safety and quality.