Simplify Your Path to MDR Compliance with Professional Guidance
The Medical Device Regulation, MDR (EU) 2017/745, is designed to ensure the safety and performance of medical devices within the EU market. This regulatory framework signifies a substantial shift in how medical devices are approved and monitored in the EU, emphasizing a more rigorous approach to clinical evidence and post-market surveillance.
With the MDR setting new precedents for the industry, ensuring your products meet these stringent requirements is more crucial than ever. Let our experts guide you on the path to compliance!
At Key2Compliance, we provide services tailored for both new medical devices and legacy products in alignment with MDR. Our goal is to assist medical device manufacturers in outpacing their competitors and maintaining and increasing their market position.
This page delivers insights into deadlines, and strategies for achieving compliance with the MDR.
To-Do list for legacy devices
transitioning to MDR!
Understanding MDR
The Medical Device Regulation (MDR) was introduced for several critical reasons, aiming to enhance the overall framework governing medical devices within the European Union.
The key reasons include:
Improved Patient Safety:
MDR aims to significantly increase the safety and reliability of medical devices on the market. By implementing stricter pre-market assessment and continuous post-market surveillance, the regulation ensures that only devices meeting high safety and performance standards reach patients.
Increased Transparency and Traceability:
The regulation introduces a comprehensive system for device identification and tracking, including the Unique Device Identification (UDI) system and the EUDAMED database. This facilitates better monitoring, allows for easier recall of devices if necessary, and enhances the availability of device information to the public and healthcare professionals.
Modernization of Regulatory
Framework:
MDR replaces the previous Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), addressing technological advances and changes in the medical device market. It aims to consolidate regulatory processes across EU member states, ensuring a consistent approach to medical device regulation and promoting a more level playing field for manufacturers.
Key changes in the transition from MDD to MDR
MDR imposes more rigorous criteria for Notified Bodies and reclassifies certain devices
into higher risk categories, subjecting them to stricter regulatory scrutiny.
The implementation of the Unique Device Identification (UDI) system improves device traceability, aiding in more efficient recalls and better patient safety.
The regulation mandates the use of the European Database on Medical Devices (EUDAMED) to enhance transparency, making detailed device information publicly accessible
MDR extends its regulatory reach to include products previously not covered under MDD, such as certain products with only an aesthetic or non-medical purpose but which are similar to medical devices in terms of functioning and risks profile, thereby tightening the safety net.
MDR requires more comprehensive clinical evidence for device approval and mandates continuous post-market surveillance to ensure ongoing safety and performance
Test your device with
our AI classifier!
How Key2Compliance can help with meeting MDR requirements
Streamlined Compliance Process: Our expert consultants specialize in navigating the complexities of MDR, helping manufacturers efficiently meet the enhanced requirements for documentation, clinical evidence, and post-market surveillance. This expertise not only reduces the time to market but also optimizes costs associated with compliance efforts.
Navigating Market Dynamics: For smaller manufacturers, the heightened requirements might seem daunting and could potentially threaten their market presence. Our experienced professionals provide strategic guidance and support, enabling these companies to remain competitive and avoid being overshadowed or absorbed by larger entities. This strategic partnership can be crucial for maintaining diversity and innovation within the market.
Enhancing Patient Safety and Product Innovation: Our Consultants play a pivotal role in ensuring that medical devices not only comply with regulatory requirements but also align with the highest safety and quality benchmarks. This drives innovation, ensuring that new devices contribute positively to patient care and healthcare outcomes.
Leveraging Global Insights: With MDR setting a new standard in medical device regulation, having a regulatory consultant with a global perspective is invaluable. We can offer insights into how MDR influences international regulatory strategies and market access, ensuring manufacturers are well-positioned not only in the EU but also in global markets.
Get expert MDR guidance from our consultants
Reach out to Key2Compliance today to discover how we can support
your company in mastering the MDR. Our team of specialists have extensive experience in guiding medical device manufacturers in pinpointing necessary adjustments for compliance, crafting a tailored regulatory strategy, meeting the necessary requirements, and supporting you throughout the conformity assessment process.
We are prepared to address all your regulatory challenges, allowing you to concentrate on innovation.
Related material
Viktigaste kraven i ISO 13485, MDR och QSReg.
3-dagarskurs för dig inom inom utveckling, tillverkning, processutveckling eller kvalitetsfunktioner
Läs mer >
A tailor-made package for MDSW manufacturers
Learn more >
Key requirements in ISO 13485, MDR, and QSReg - Training for R&D, production, process development and QA.
Copenhagen, June 25-27
Learn more and register >
A package including training, GAP analyses and audit
Learn more >
Read article>
FAQ about the Medical Device Regulation (MDR)
The Medical Device Regulation (EU 2017/745) is a legislative framework enacted by the European Commission to ensure the safety and performance of medical devices sold within the EU. It replaces the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), providing more stringent requirements for medical device manufacturers.
The MDR officially came into effect on May 26, 2021, following a transition period that allowed manufacturers, notified bodies, and national competent authorities to prepare for the new regulatory requirements.
The MDR affects a wide range of stakeholders within the medical device industry, including manufacturers, importers, distributors, notified bodies, and healthcare providers in the EU. It also impacts manufacturers outside the EU who wish to market their medical devices within the EU.
Key changes include stricter clinical evidence requirements, enhanced post-market surveillance, the introduction of the Unique Device Identification (UDI) system for better traceability, broader scope of regulated products, increased transparency, and more rigorous oversight of notified bodies.
The UDI system is a key component of the MDR aimed at improving the traceability of medical devices. It requires devices to be marked with a unique identifier, facilitating better monitoring, easier recalls if necessary, and enhanced patient safety.
MDR introduces changes to the classification system, potentially reclassifying some devices into higher risk categories based on their intended use and potential risks. This reclassification may subject devices to more stringent regulatory requirements.
Manufacturers should conduct a thorough gap analysis to identify areas of non-compliance, update their quality management systems, enhance clinical evaluation and post-market surveillance processes, and ensure all technical documentation meets MDR requirements. Engaging with regulatory experts or consultants can also provide valuable guidance and support.
Non-compliant devices are not allowed to be placed on the EU market. Manufacturers of non-compliant devices may face legal consequences, including fines, withdrawal of their products from the market, and damage to their reputation.
Yes, devices that are lawfully placed on the market under the MDD after May 26, 2021, so called legacy-devices, and that are not going to be transitioned to MDR can continue to be made available on the market until May 26 2024, under certain conditions. However, significant changes to such devices may require compliance with MDR.
For devices transitioning to the MDR from the MDD, the following dates apply:
– 26 May 2026 for class III implantable custom-made devices
– 31 December 2027 for class III and implantable class IIb devices
– 31 December 2028 for non-implantable class IIb and lower risk devices
– 31 December 2028 for class I devices that re higher class under the MDR
Under the MDR, certain products with only an aesthetic or another non-medical intended purpose but which are similar to medical devices in function and risk profile (e.g., cosmetic contact lenses and, dermal fillers) are now regulated under the MDR. This means they must comply with the same rigorous safety and performance requirements as traditional medical devices.
The MDR requires that clinical evidence must be gathered through clinical investigations to support the safety and performance claims of a device. This evidence must be documented in a Clinical Evaluation Report (CER) and updated regularly with post-market surveillance data to reflect ongoing safety and performance.
Whereas software as a medical device (SaMD) is an international term, the MDR uses the concept medical device software (MDSW). MDSW includes not only standalone software, SaMD, but also software that is part of a hardware medical device. The MDR qualifies software as or in a medical device based on its intended purpose. In order to be qualified as a medical device software (MDSW), the software must have a medical purpose on its own. Software intended to, for example, provide information for diagnostic or therapeutic purposes falls under the regulation and must comply with the same requirements as physical medical devices, including clinical evaluation and post-market surveillance.
Notified Bodies are independent organizations designated by EU member states to assess the conformity of certain products before being placed on the market. Under the MDR, Notified Bodies have increased responsibilities, including more stringent requirements for designation and the obligation to conduct unannounced audits and product testing.
While MDR certification is specific to marketing devices within the European Union, it is often viewed as a mark of high quality and compliance with rigorous safety standards. Many countries outside the EU recognize or align their regulations with EU standards, potentially facilitating market access. However, manufacturers must still comply with the specific regulatory requirements of each country where they intend to market their devices.
The MDR increases the regulatory burden on manufacturers, potentially leading to higher costs associated with achieving and maintaining compliance. These costs include more extensive clinical evaluations, increased post-market surveillance activities, and the need for more detailed technical documentation. While this may increase the cost of market entry, it also emphasizes the safety and performance of medical devices, potentially leading to long-term benefits for manufacturers through enhanced product quality and patient trust.
Recognizing the challenges faced by SMEs, the European Commission and some member states offer guidance documents, digital tools, and sometimes financial support to help SMEs navigate MDR compliance. At GBA Key2Compliance we provide expert guidance for SMEs with regulatory strategies and compliance solutions tailored to their specific needs and resources.
