Establishing a robust Quality Management System (QMS) is a cornerstone of regulatory compliance for medical device manufacturers operating in the European Union. The EU Medical Device Regulation (MDR) (Regulation (EU) 2017/745) requires every manufacturer to implement and maintain a QMS covering the entire lifecycle of their devices—from design and development through post-market activities.
While the MDR does not mandate that this QMS be certified (for example, to EN ISO 13485:2016), it does stipulate that manufacturers must demonstrate, at any time, that their system meets the regulatory obligations defined in Article 10. Without a functioning and well-documented QMS, it is not possible to legally place devices on the EU market.
If you intend to appoint Advena as your EU Authorised Representative (EC REP), you will be expected to provide documented QMS procedures as part of your application. These procedures form the foundation of regulatory oversight and demonstrate that you are actively controlling every stage of your product’s lifecycle.
Why a QMS Matters Under MDR
Many manufacturers already operate to recognised standards such as EN ISO 13485:2016 or MDSAP. These certifications offer an excellent starting point, but the MDR introduces additional regulatory expectations.
For Class I devices, Article 10 outlines the minimum QMS obligations that every manufacturer must fulfil, including risk management, post-market surveillance, and regulatory compliance strategies. For higher-risk classes (IIa, IIb, and III), the requirements are even more rigorous and subject to notified body assessment.
As your EU Authorised Representative, Advena requires documented procedures covering at least the following areas:
- Change management
- Strategy for regulatory compliance
- Resource management
- Product realisation
- Vigilance
- Communication with stakeholders
- Monitoring, measurement, data analysis, and improvement
- Business continuity if activities cease
- Device registration
- UDI assignment and traceability
These may be compiled as individual procedures or integrated into your Quality Manual.
Guidance on Key Procedures
Below is an expanded overview of the essential elements your QMS must address.
Management Responsibility
Top management must actively demonstrate commitment to a compliant QMS by:
- Defining their responsibilities.
- Conducting regular management reviews covering regulatory changes, vigilance, complaints, and improvements.
Product Realisation
This covers design, development, manufacture, and delivery. The procedure should include:
- Considering MDR requirements, harmonised standards, and Common Specifications from the outset.
- Risk management in line with Annex I MDR.
- UDI generation, maintenance, and assignment.
- Verification and validation of product and processes, including preclinical evaluation.
- Planning of design, development, production, and service provision.
- Translation of labels and IFUs for the countries where the device is marketed.
- Ensuring labels are clear, indelible, and comprehensible.
- Record retention for at least 10 years (15 for implantables).
Risk Management
Manufacturers must implement risk management in accordance with Annex I MDR and ISO 14971. This applies both to devices and to the QMS itself.
Technical Documentation
Your technical file must comply with Annexes II and III MDR and cover:
- Device classification, CE marking, and Declaration of Conformity.
- Labels, IFUs, and translations.
- Clinical evaluation and PMCF (Annex XIV).
- Demonstration of compliance with the General Safety and Performance Requirements (Annex I).
- Post-Market Surveillance (PMS) planning and reporting.
Unique Device Identification (UDI)
A dedicated procedure must detail:
- Generation and maintenance of Basic UDI-DI and UDI.
- Verification, storage, and labelling of UDIs.
- Traceability requirements under Article 29 MDR.
Document & Record Control
Procedures must ensure documents and records are properly reviewed, approved, maintained, and retrievable. Retention periods: 10 years (15 for implantables).
Communication with Stakeholders
Manufacturers need a system to communicate with:
- Competent Authorities
- Authorised Representative
- Importers and distributors
- Customers
This must cover reporting obligations, provision of samples/documents, and permanent access to required files.
Strategy for Regulatory Compliance
Your regulatory compliance strategy should describe:
- How applicable requirements are identified and implemented.
- How product design is adapted to meet these requirements.
- Training, regulatory updates (e.g. newsletters), and industry memberships to stay informed.
Resource Management
Manufacturers must establish how they provide:
- Human resources, infrastructure, and controlled work environments.
- Supplier evaluation, monitoring, and re-evaluation.
Post-Market Surveillance & Vigilance
Procedures must be in place for:
- PMS activities under Article 83 MDR, including data from feedback and complaints.
- Vigilance reporting of incidents and Field Safety Corrective Actions (FSCAs) in line with MDR and MEDDEV 2.12-1 rev.8, with defined timelines and reporting methods.
Corrective & Preventive Actions (CAPA)
A CAPA system must ensure identification, implementation, and documentation of actions to maintain device safety, performance, and QMS effectiveness.
Monitoring & Measurement
Manufacturers must continually monitor product and QMS performance through data collection, complaint handling, and analysis of nonconformities.
Business Continuity
If a manufacturer ceases trading, safeguards must ensure device safety and performance monitoring continues. Relevant documents must be handed over to the Authorised Representative or Competent Authority.
Registration
Manufacturers must have a process for EU device registration. Currently, only Class I devices are registered through the Authorised Representative, but future use of EUDAMED is expected.
Final Note
Meeting these requirements establishes only the minimum QMS expected under MDR. Aligning with EN ISO 13485 will provide a much stronger framework for compliance and long-term success.
If you need expert guidance in building or updating your QMS, Advena can help. Contact us today for tailored support and a quote.
