"The standards for European market authorisation have undergone a significant transformation with the implementation of Regulation (EU) 2017/745 (MDR). The MDR creates a high-stakes environment where compliance is no longer a "point-in-time" event but rather a continuous lifetime duty. At QHS Certification, we offer the professional supervision and technical infrastructure needed to guarantee your place in the European Single Market."
The Development of Class I: Comprehending the Risk Subclasses
The risk-based classification system is preserved by the MDR, but it adds important technical improvements through "subclasses." Identifying the correct conformity assessment route for your device is the foundational step in your regulatory strategy.
Under Annex VIII of the MDR, Class I devices are those with the lowest risk profile. However, if your device has certain features, it might belong to one of the following subclasses, each of which calls for a Notified Body's intervention:
• Class Is (Sterile): Devices that are sold in a sterile state. The areas of manufacturing related to creating, preserving, and verifying sterile conditions are the special focus of the Notified Body audit.
• Class Im (Measuring): Devices with a measuring function must have their accuracy and metrological requirements verified by a Notified Body.
• Class Ir (Reusable Surgical Instruments): Reusable instruments now require Notified Body validation of the manufacturer's reprocessing instructions, including cleaning, disinfection, and sterilization cycles.
For standard Class I devices (non-sterile, non-measuring, and non-reusable), the manufacturer continues to utilize the Self-Certification route. However, this is not a simplified path; it is a legal declaration of full compliance with every relevant article of the 175-page Regulation.
Definitive Technical File Checklist for MDR Compliance (Annex II & III)
A compliant Technical File is the "source of truth" for your device. Under the MDR, documentation must be presented in a "clear, organized, readily searchable, and unambiguous manner." We recommend the following structured framework for building a defensible technical dossier:
I. Device Description and Specification
• Basic UDI-DI Assignment: Integration of the Unique Device Identifier into the technical dossier and registration within EUDAMED.
• Intended Purpose Statement: A rigorous definition of the medical indication, target patient population, and contraindications.
• Classification Rationale: A formal legal justification citing the applicable rules within Annex VIII.
• Principles of Operation: An explanation of the device’s mode of action, supported by engineering drawings or technical schematics.
II. Manufacturer Specification
• Labelling and Packaging Design: Comprehensive drafts of labels for the unit, secondary packaging, and transport containers.
• Use Instructions (IFU): Expert modifications for each target EU Member State that follow EN ISO 15223-1 symbols.
III. Manufacturing and Design Verification
Information Design: A data-driven proof that the gadget satisfies user needs and design inputs.
Flowcharts for Manufacturing: Listing all locations used for design and production, along with significant subcontractors and validated "Special Processes."
IV. GSPR (General Safety and Performance Requirements)
• Mapping Annex I: A thorough checklist that demonstrates how the gadget satisfies each pertinent GSPR.
• Conformity Presumption: Evidence of adherence to unified European standards, including EN ISO 13485:2016 and EN ISO 14971:2019 (Risk Management).
V. Clinical Assessment and Risk Management
Clinical Evaluation Report (CER): Under the MDR, even Class I devices need a CER. This report must provide a critical assessment of clinical data and use academic literature or equivalence data to show performance and safety.
Risk Management File: A systematic approach to identifying, evaluating, and mitigating risks throughout the life of the equipment.
The Importance of Class I Device Clinical Assessment
A common misconception is that Class I devices are exempt from clinical rigour. Every medical device, irrespective of their class, must have adequate clinical data to support their performance and safety (Article 61).
For many Class I manufacturers, this evidence is gathered via the Literature-Based Route. This involves a systematic search of clinical databases to identify data relating to your device or an "equivalent" device. However, "Equivalence" under the MDR has become much harder to prove, requiring technical, biological, and clinical similarity. QHS Certification assists you in bridging the gap between high standards of proof and your current data.
Whole Life Cycle Commitment to Post-Market Surveillance (PMS)
Your regulatory responsibilities continue after you have the CE Mark. Every manufacturer is required by Article 83 to set up a proactive PMS System. For Class I devices, this comprises:
• PMS Plan: A method for continuously gathering performance data in the actual world.
• Post-Market Surveillance Report (PMSR): An overview of results and any remedial measures. National Competent Authorities must have regular access to this.
• Vigilance & Incident Reporting: Organised procedures for reporting major occurrences or Field Safety Corrective Actions (FSCAs) within legal timeframes.
Technical Integrity to Gain a Competitive Edge
The Technical File is a strategic asset for multinational firms. The EU, EEA, Switzerland, and Turkey are the 32 nations that comprise the European Single Market. The CE Mark is your permit to trade there, but its validity depends on the technical information it contains.
Strong technical files lower liability risks, avoid expensive product recalls, and increase confidence among distributors and healthcare providers. QHS Certification provides expert guidance to manage EUDAMED registration, SRN acquisition, and Authorized Representation, ensuring your regulatory strategy meets the current criteria of the MDR.
