Introduction
In the European healthcare landscape, medical device certification has become, in recent years, one of the most rigorous and complex regulatory processes in the world. Regulation (EU) 2017/745, commonly known as the MDR (Medical Device Regulation), has substantially redefined the rules for accessing the European market, replacing the previous MDD and AIMDD Directives with a regulatory framework that is more demanding in terms of clinical safety, transparency, and post-market surveillance.
Understanding this pathway is essential not only for manufacturers but also for healthcare professionals who daily use CE-certified medical devices, and for all economic operators (distributors, importers, etc.) who interact with these regulatory systems.
1. The Regulatory Framework: From MDD to MDR
The MDR entered into force on 26 May 2021, five years after its publication in the Official Journal. Some requirements were made mandatory immediately upon entry into force (post-market surveillance, vigilance, registration of economic operators), while certification deadlines, initially set by the MDR and later revised and extended by Regulation (EU) 2023/607, established transition periods based on device classification (31 December 2027 for Class III and high-risk implantable Class IIb devices, and 31 December 2028 for non-implantable Class IIb, IIa, Is, and Im devices).
In general, the MDR’s entry into force has brought a significant increase in requirements compared to the previous directives, with particular focus on:
- More robust clinical evidence and more detailed technical documentation
- Strengthened requirements for high-risk devices (Class III and implantable Class IIb)
- Implementation of the EUDAMED system (European Database on Medical Devices)
- Introduction of the UDI (Unique Device Identification) system for traceability
- Stricter post-market surveillance (PMS) and vigilance obligations
A major development has been the creation of a European database (EUDAMED) involving all manufacturers, importers, and notified bodies, with the aim of consolidating all information related to medical devices, including product registrations, certificates, incident reports, clinical studies, and post-market surveillance data, into a single centralised system accessible to competent authorities. From May 2026, several EUDAMED modules will become fully operational and therefore mandatory.
2. Risk Classification
The first step in the certification pathway is the correct classification of the device according to the rules set out in Annex VIII of the MDR, which distinguishes four classes of increasing risk:
- Class I — Low risk (e.g. bandages, corrective eyeglasses)
- Class IIa — Medium-low risk (e.g. biopsy needles, catheters)
- Class IIb — Medium-high risk (e.g. non-active implantable devices, ventilators)
- Class III — High risk (e.g. implantable prostheses, coronary stents)
Classification is not merely a formality: it determines the type of conformity assessment procedure applicable, the level of involvement of the Notified Body, and the depth and comprehensiveness of the technical and clinical documentation required to support the device’s safety and performance.
3. The Quality Management System (QMS) According to ISO 13485
Regardless of risk class, every manufacturer must implement a Quality Management System compliant with ISO 13485:2016, specifically designed for the medical device industry. The QMS forms the operational backbone of the entire compliance system and must cover the entire device lifecycle, from design to distribution, and from production to complaint handling and market withdrawal.
For non-sterile Class I devices without a measuring function, the manufacturer may proceed by self-declaration. For all higher classes, the QMS must be verified and certified by an accredited Notified Body (NB).
The entry into force of the MDR has also had an impact at the Quality Management System level. Manufacturers have had to draw up an impact assessment plan and implement activities to meet the new requirements.
4. Technical Documentation
The technical documentation, governed by Annexes II and III of the MDR, forms the core of the dossier and must include:
- Description and specifications of the device, including all components and accessories
- Manufacturing information (production processes, quality control, sterilisation)
- General Safety and Performance Requirements assessment (GSPR, Annex I)
- Risk analysis and risk management according to ISO 14971
- Verification and validation data (laboratory tests, biocompatibility testing)
- Clinical Evaluation Plan and Report (CER)
- Post-market surveillance plan and report (PMSP and PMSR/PSUR)
- Post-market clinical follow-up plan and report (PMCFP and PMCFR)
- Labelling and Instructions for Use (IFU)
The quality of the technical documentation is one of the most critical aspects of the process: gaps or inconsistencies in the dossier are among the most frequent causes of delays in certification.
5. Clinical Evaluation
One of the most innovative and demanding aspects of the MDR is the strengthening of clinical evidence requirements. The manufacturer must demonstrate, through a systematic and up-to-date Clinical Evaluation Report (CER), that the device achieves its intended performance and that residual risks are acceptable in relation to clinical benefits.
The clinical evaluation is based on a systematic review of the scientific literature (clinical equivalence), data from proprietary clinical studies and/or registries, and analysis of post-market data. For Class III devices and certain implantable Class IIb devices, the MDR provides for the possibility that the Notified Body consults a panel of scientific experts (Expert Panel) prior to issuing the certificate.
6. The Role of the Notified Body (NB)
Notified Bodies are third-party organisations, accredited and designated by national competent authorities, responsible for the independent conformity assessment of Class IIa, IIb, and III devices. Their role encompasses:
- Auditing the manufacturer’s Quality Management System
- Reviewing the technical documentation and CER
- Evaluating product samples, where relevant
- Issuing the conformity certificate (EU QMS Certificate and/or EU Technical Documentation Assessment Certificate)
Access to Notified Bodies has become a significant bottleneck in the MDR system: the number of designated NBs is still below industry demand, resulting in waiting times that can exceed 12–18 months for higher-risk classes.
7. The Declaration of Conformity and CE Marking
Once the conformity assessment has been successfully completed, the manufacturer draws up the EU Declaration of Conformity in accordance with Annex VII of the MDR, a legally binding document by which the manufacturer assumes responsibility for the device’s compliance with the MDR. Only at this point may the device be affixed with the CE marking and placed on the European market.
For non-EU manufacturers, it is mandatory to designate an Authorised Representative (AR) established within the European Union, who assumes specific regulatory responsibilities vis-à-vis the competent authorities.
8. Post-Market Surveillance
The MDR has significantly strengthened post-market surveillance obligations, which are now regarded not as a residual activity but as an integral and proactive part of the device lifecycle. The PMS system includes:
- Post-market surveillance plan (PMSP) with objectives and data collection methods
- Periodic safety update report (PSUR) for Class IIa, IIb, and III devices
- Post-market surveillance report (PMSR) for Class I devices
- Vigilance system for reporting serious incidents and field safety corrective actions (FSCA) to Notified Bodies and competent authorities
9. What’s Coming: The European Commission’s Simplification Proposal
On 16 December 2025, the European Commission adopted a proposal to amend the MDR and IVDR with the stated aim of simplifying the regulatory framework, reducing the administrative burden, and improving the predictability of the certification process, while maintaining high patient safety standards.
Key elements of the proposal include the introduction of priority procedures for ‘Breakthrough Devices’ (innovative devices with a significant positive clinical impact for potentially life-threatening conditions) and for ‘orphan’ devices (indicated for conditions affecting fewer than 12,000 individuals in the EU annually). The proposal is now in the legislative process before the European Parliament and the Council.
10. BPB MEDICA™’s Approach to MDR Compliance
As an Italian manufacturer of medical devices for minimally invasive surgery, BPB MEDICA™ has structured its quality system and product development process in full compliance with the requirements of the MDR. The vertical integration of production, from design to in-house manufacturing, allows for thorough control of every phase of the device lifecycle, a fundamental element in meeting the stringent regulatory compliance and traceability requirements of the European regulation.
A deep understanding of the regulatory pathway is not for us a mere compliance obligation: it is a commitment to patient safety and to the trust of the healthcare professionals who use our devices every day.
