EU Medical Device Regulation (MDR)
Our experts provide EU MDR guidance at each step of the way so your company transitions efficiently and successfully.
The Overall MDR Certification Process
The journey to MDR certification for devices requiring Notified Body (NB) involvement typically follows a sequence of key stages, although specific NB processes may vary slightly. It generally begins with the manufacturer submitting a formal application to their chosen NB. This initial phase involves pre-application information review and verification by the NB to confirm the product is a medical device under MDR, its classification, and the applicability of the NB's designation scope. This leads to the conclusion of a written agreement between the manufacturer and the NB. Data suggests this initial application process, culminating in the written agreement, typically takes between 1 to 3 months for the majority of MDR applications.
Following the agreement, the core conformity assessment activities commence. These usually involve:
1. Quality Management System (QMS) Audit: The NB assesses the manufacturer's QMS for compliance with MDR requirements (Article 10(9)), covering areas like design controls, manufacturing, risk management, PMS, and documentation maintenance.
2. Technical Documentation Assessment: The NB reviews the manufacturer's Technical Documentation (TD) against MDR requirements (Annexes II and III), with the depth and methodology varying by device classification.
3. Device Testing (if applicable): Depending on the device and conformity route, specific product testing may be required.
4. Certification Decision: Based on the outcomes of the QMS audit and TD assessment, the NB makes a decision on issuing the MDR certificate.
Only “legacy devices” can benefit from the extended transitional period. In line with MDCG 2021-252 “legacy devices” should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26 May 2021) if certain conditions are fulfilled.
Those devices can be:
• Devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
• Devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.
It is important to recognize that these stages are often interconnected and may occur iteratively rather than strictly sequentially. For instance, findings during a QMS audit might necessitate updates to the TD, or questions arising from the TD review might require clarification related to QMS procedures.
The overall certification timeline, often cited as 13-18 months or even up to 24 months, reflects the cumulative duration of all these activities, including:
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NB review time
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Manufacturer response times to queries
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Potential queue times due to NB workload.
Therefore, the TD review duration is not an isolated metric but is intrinsically linked to the efficient progression through the entire conformity assessment pathway. Delays in the initial 1-3 month application and agreement phase, or significant non-conformities identified during the QMS audit, will inevitably push back the commencement or extend the duration of the subsequent TD review phase.
The certification timelines are heavily influenced by three dominant factors:
1. Notified Body Capacity: Persistent limitations in NB availability and significant backlogs remain a critical external constraint affecting all stages of the certification process.
2. Manufacturer Preparedness: The quality, completeness, and clarity of the submitted technical documentation are paramount and represent the most significant area under the manufacturer's control to influence review efficiency.
3. Device Complexity: The inherent nature of the device, including its risk class, novelty, and technological complexity, directly impacts the depth and duration of the required review.
While predicting exact timelines is fraught with uncertainty, manufacturers are not passive participants in the process. By investing significantly in meticulous preparation to create high-quality, unambiguous technical documentation, engaging proactively and strategically with their chosen Notified Body, developing robust clinical evidence, and adopting realistic planning horizons that account for potential delays, companies can substantially improve their chances of navigating the MDR certification pathway efficiently.
Success under the demanding MDR framework ultimately requires a strategic, well-resourced, lifecycle-focused approach to regulatory compliance.
How we can help:
BioVision’s consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR).
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EU MDR 2017/745 Gap Assessment and CE Transition Strategy for Medical Device Manufacturers.
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Helping with strategy planning and finance consulting.
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On-Site Medical Devices Regulation (EU MDR) Training for Manufacturers.
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MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices.
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EU MDR compliance consulting for devices that do not have a medical intended purpose (Annex XVI).
Key changes MDR versus MDD:
Product scope expansion
The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that do not have a medical intended purpose (Annex XVI).
Reclassification of devices according to risk, contact duration, and invasiveness
The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
Clinical evidence for class III and implantable medical devices
Manufacturers will need to conduct clinical investigations if they do not have sufficient clinical evidence to support the claims for both safety and performance aspects of a dedicated device.
Clinical evaluation of Class IIa and Class IIb medical devices
Manufacturers will need to revise their clinical evaluation by considering the new wording of the regulation for an equivalence approach and under which circumstances it is possible to justify not to conduct a clinical investigation.
Post-market Surveillance
The MDR request increased post-market surveillance authority by the Notified Body.
Identification of the " Person Responsible for Regulatory Compliance (PRRC)"
Device manufacturers will be required to establish the role of the Person Responsible for Regulatory Compliance (PRRC) within their organization who is ultimately responsible for
all aspects of compliance with the requirements of the new regulation.
Implementation of unique device identification
The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain.