Applus+ Laboratories is your accredited partner for EU Medical Device Regulation (MDR) certification. We are a fully designated Notified Body, providing conformity assessment services for your medical devices intended for the European market. The transition to Regulation (EU) 2017/745 (MDR) has raised the bar for quality and safety. Applus+ Laboratories provides the expert guidance and accredited services you need to navigate this complex landscape with confidence. We offer a clear, structured, and efficient pathway to ensure your devices achieve and maintain compliance.
What Is the EU Medical Device Regulation?
The EU Medical Device Regulation (MDR) is the most significant update to European medical device law in decades, replacing the former Medical Device Directive (MDD). Unlike a directive, which requires translation into national law, the MDR is a regulation with binding legal force across all EU member states. This creates a harmonised, predictable, and robust regulatory framework. Its primary goal is to enhance patient safety through a comprehensive, lifecycle-based approach to device regulation, extending rigorous oversight from initial concept through to post-market surveillance.
Why Is EU MDR Essential for Your Device's Safety and Market Access?
Compliance with the EU MDR is not just a regulatory hurdle; it is a commitment to the highest standards of patient safety and a prerequisite for market access. The regulation ensures that all medical devices undergo rigorous scrutiny to prove their safety and performance claims.
For manufacturers, achieving MDR certification is the key that unlocks the European market of over 450 million people. It demonstrates your dedication to quality and provides a competitive advantage, building trust with healthcare providers, partners, and patients alike.
Key Requirements and Changes Introduced by EU MDR
The MDR introduces several critical changes and heightened requirements that manufacturers must address. Understanding these pillars is the first step toward successful certification.
- Expanded Scope: The regulation now covers a broader range of products, including certain devices without a medical purpose (e.g., cosmetic implants, dermal fillers) and devices used for cleaning or sterilising other medical devices.
- Stricter Clinical Evidence: The MDR demands more robust clinical evidence to substantiate safety and performance claims. The reliance on data from "equivalent" devices is now severely restricted, often necessitating new clinical investigations and continuous data collection throughout the product lifecycle (PMCF).
- Enhanced Traceability (UDI System): The mandatory Unique Device Identification (UDI) system provides unambiguous traceability for every device throughout the supply chain, enhancing the effectiveness of post-market safety activities like recalls and vigilance reporting.
- Increased Transparency (EUDAMED): The European Database on Medical Devices (EUDAMED) is a publicly accessible hub for device information, including certificates, clinical investigations, and vigilance reports, leading to greater scrutiny from regulators and the public.
- Total Lifecycle Approach: The regulatory focus has shifted from pre-market approval to a holistic view of the entire product lifecycle, mandating proactive Post-Market Surveillance (PMS) and continuous updates to technical documentation.
What Is the Difference Between US and EU Medical Device Regulations?
While both frameworks aim for high safety standards, the EU and US regulatory pathways have distinct structural differences. The US system is centralised under the FDA, which clears devices through established routes like the 510(k) or Premarket Approval (PMA) processes.
In contrast, the EU’s MDR employs a decentralised model, where manufacturers partner with a designated Notified Body. The MDR is also distinguished by its strong emphasis on a total lifecycle approach, mandating more rigorous clinical evidence, enhanced transparency through the EUDAMED database, and comprehensive traceability via the UDI system.
Navigating the EU MDR Auditing and Certification Process with Applus+ Laboratories
We believe in a transparent, predictable, and collaborative certification journey. Our four-phase process is designed to provide clarity and support at every stage, enabling you to navigate the certification journey with confidence and thorough preparation.
- Phase 1: Structured Dialogue: Your journey begins with a clear and structured dialogue, which takes place before you submit an initial application. This allows us to conduct a feasibility check to confirm your device falls within our designation scope and also to clarify the timing, procedural, and regulatory aspects of the application process, including the required forms and submission documents, possible options, special procedures, acceptable languages, timelines to be respected, fees charged for specific conformity assessment activities, as well as determining the most appropriate conformity assessment route based on your device's risk class (I, IIa, IIb, or III). This is a strategic decision that impacts all future regulatory activities. The most common path is Annex IX, a comprehensive assessment of your Quality Management System (QMS) and Technical Documentation. Other routes, such as Annex XI - Part A (Production Quality Assurance), may also be applicable, focusing on the assessment and ongoing surveillance of the manufacturer’s quality system related to production and final product inspection.
- Phase 2: Application and Engagement: Following a formal agreement, we assign a dedicated project leader to be your consistent point of contact. Once you submit your application, a critical next step is a completeness check of your submitted Technical Documentation to ensure all required elements are present before the in-depth assessment begins, preventing unnecessary delays.
- Phase 3: Assessment Activities: Our expert team conducts the core assessment activities. This multifaceted evaluation includes a two-stage QMS audit (a Stage 1 readiness review followed by a Stage 2 on-site implementation audit) and a rigorous Technical Documentation review. The depth of this review is dictated by risk class—from representative sampling for Class IIa/IIb devices to scrutiny of every file for Class III and implantable Class IIb devices (excluding WET devices). A critical component of this is the Clinical Evaluation Assessment, where our clinical experts verify that your safety and performance claims are robustly supported by high-quality clinical evidence.
- Phase 4: Certification and CE Marking: The final phase leads to a formal decision. If any areas of non-conformity are identified during the audit, you will be required to submit a corrective action plan. Once all issues are resolved, an independent internal panel, separate from the audit team, makes the final certification decision to ensure complete impartiality. Upon a positive outcome, we issue the necessary MDR certificates. This empowers you to draw up your EU Declaration of Conformity and, as the final step, affix the CE marking to your device, signifying it can be legally placed on the EU market.
EU MDR Transition Periods and Staying Ahead with Applus+ Laboratories
While the primary transition deadlines have passed, continuous compliance is an ongoing journey. The MDR requires a permanent commitment to lifecycle management. Manufacturers with legacy devices still on the market under valid MDD certificates must be vigilant; any "significant change" to the device's design or intended purpose will trigger the need for full MDR certification.
Our post-certification monitoring activities, including annual surveillances and unannounced audits, ensure your QMS remains effective. Our role includes verifying the ongoing requirements for Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSURs), transforming continuous compliance from a challenge into a manageable and predictable business process.
Why Choose Applus+ Laboratories for MDR Certification?
Choosing a Notified Body is a critical strategic decision. Partnering with Applus+ Laboratories means choosing a dedicated team invested in your success. Here is what sets us apart:
- Our Proven Expertise: Applus+ Laboratories is a fully designated Notified Body. This isn't just a title; it's your assurance that we hold the official authorisation and possess the deep in-house technical, clinical, and regulatory expertise required to assess your specific medical device technology.
- Our Partnership Approach: At Applus+ Laboratories, we believe in collaboration. You will be assigned a dedicated project leader from our team, ensuring you have a consistent, single point of contact. We don't just audit; we build a long-term partnership focused on safety and sustained compliance.
- Our Commitment to Transparency: We eliminate uncertainty. The Applus+ Laboratories process is built on clear communication of all steps, timelines, and requirements from the start. Our publicly available fee schedule ensures you can budget effectively with no surprises.
- Our Focus on Efficiency: Your time and resources are valuable. The Applus+ Laboratories structured process is designed for efficiency and predictability, providing a clear framework for navigating the conformity assessment process.
- Our Global Network: With Applus+ Laboratories, you benefit from our global network of experts. We serve clients worldwide, providing the seamless and responsive service needed to access the highly regulated EU market, no matter where you are located.