Who is considered a manufacturer under MDR?
A manufacturer under the MDR regulation is any natural or legal person who designs, manufactures, or has a medical device manufactured and places it on the market under their own name or brand. If the manufacturer is not established within the European Economic Area, they are required to appoint an authorised representative responsible for representing them before Member State authorities and ensuring the device’s compliance with MDR requirements.
Core obligations of a manufacturer under MDR
The manufacturer’s responsibilities under MDR cover the entire lifecycle of the device — from classification and documentation development to post-market activities. The manufacturer must:
- determine the risk class of the device according to Annex VIII of the MDR,
- prepare complete technical documentation,
- implement a quality management system compliant with ISO 13485,
- ensure compliance with GSPR requirements,
- complete the appropriate conformity assessment procedure,
- affix the CE mark and assign a UDI number,
- register the device and the manufacturer in the EUDAMED system,
- implement PMS and vigilance mechanisms.
Quality management system
Every manufacturer must maintain a quality management system (QMS) covering the entire lifecycle of the device: design, production, control, complaint handling, and post-market activities. The system should be built around MDR requirements and ISO 13485 certification to facilitate audits and communication with the notified body.
Technical documentation
Technical documentation is the basis for demonstrating conformity with MDR. It must include a description of the design, intended purpose, clinical or preclinical study results, risk assessment, and references to harmonised standards. Technical documentation must be updated regularly and is reviewed during audits by the notified body.
Person Responsible for Regulatory Compliance (PRRC)
According to Article 15 of MDR, every manufacturer must appoint a Person Responsible for Regulatory Compliance (PRRC) with relevant qualifications and professional experience in medical devices. The PRRC oversees documentation, PMS, vigilance, and ensures regulatory compliance throughout the organisation.
Reporting obligations and post-market surveillance
The manufacturer must establish a PMS system to collect data on safety and clinical performance. In case of incidents, they must report them to the competent authority within the required timeframe. The vigilance system should be part of the integrated QMS to enable prompt responses to adverse events.
Manufacturer’s insurance
Article 10 of MDR requires manufacturers to have sufficient financial coverage for potential liability. This can be fulfilled by obtaining a product liability insurance policy that covers damages caused by non-compliant medical devices. The policy must correspond to the type, class, and clinical risk of the device.
Common mistakes made by manufacturers
Typical errors include incorrect device classification, incomplete technical documentation, inadequate risk analysis, failure to implement a QMS before submitting to the notified body, delayed PRRC appointment, or lack of clinical data demonstrating product safety and effectiveness.
MDR changes and new obligations from 2025
Amendment MDR 2025/1021 introduces updates to the use of active EUDAMED modules, expands PRRC responsibilities regarding PMS and vigilance, shortens incident reporting deadlines, and imposes new obligations related to product shortage monitoring. Manufacturers will need to adapt their QMS and operational procedures to comply with the new provisions.
How Pure Clinical supports manufacturers
Pure Clinical assists medical device manufacturers in complying with MDR requirements through:
- conducting regulatory compliance audits,
- implementing and maintaining an ISO 13485-compliant QMS,
- developing and updating MDR-compliant technical documentation,
- collaborating with notified bodies during certification processes,
- integrating PMS and vigilance into the overall quality system.
Our support reduces regulatory risks and shortens the time needed to bring medical devices to market successfully.
FAQ
Can a manufacturer based outside the EU register a medical device in EUDAMED independently?