Article 10 — General Obligations of Manufacturers
Source: EU MDR 2017/745 Article 10 | OJ L 117, 5.5.2017
Core Requirements
Before placing a device on the market or putting it into service, manufacturers shall ensure that the device has been designed and manufactured in accordance with this Regulation.
10.1 — Quality Management System (QMS)
Manufacturers shall establish, document, implement, maintain, update and continuously improve a quality management system covering at least:
- A regulatory compliance strategy, including conformity assessment procedures and device change management
- Identification of applicable GSPRs and exploration of options to meet those requirements
- Responsibilities for design and development of devices
- Management of production and service provision
- Risk management (see Annex I GSPR)
- Clinical evaluation (see Annex XIV), including PMCF
- Labelling and packaging
- Post-market surveillance (PMS), including PMCF (see Annex III)
- Communication with competent authorities, notified bodies, economic operators, customers and/or other relevant parties
- Processes for information transfer and coordination between economic operators
- Reporting of serious incidents and field safety corrective actions
- Corrective and preventive actions and verification of their effectiveness
10.2 — Technical Documentation
Manufacturers shall draw up, keep up to date and make available technical documentation in accordance with Annex II and Annex III.
10.3 — Conformity Assessment
Manufacturers shall subject their devices to the applicable conformity assessment procedure as set out in Article 52.
10.4 — EU Declaration of Conformity
Manufacturers shall draw up an EU declaration of conformity in accordance with Article 19 and affix the CE marking to the device (see Article 20).
10.9 — Authorised Representative
Manufacturers established outside the EU shall designate a single authorised representative (AR) within the EU.
10.12 — Person Responsible for Regulatory Compliance (PRRC)
Manufacturers shall ensure that they have at least one person responsible for regulatory compliance (PRRC) with the requisite expertise in the field of medical devices.
PRRC Responsibilities:
- Ensure that the conformity of the devices is appropriately checked before release
- Ensure that the technical documentation and the EU declaration of conformity are drawn up and kept up to date
- Ensure that post-market surveillance obligations are fulfilled
- Ensure that the reporting obligations for serious incidents and field safety corrective actions are fulfilled
- Ensure that, in the context of investigations, the necessary support is provided to competent authorities
Related Articles
- Article 52 — Conformity Assessment Procedures
- Annex I — GSPR
- Annex II — Technical Documentation
- Annex XIV — Clinical Evaluation