The definition of Manufacturer means:
‘the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under his name or trademark.’
In other words: the entity that markets the device with its name or trademark on the device is the manufacturer!
Manufacturer’s General Obligations:
(Article 10 of the MDR as published per Q2/2017)
1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.
2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.
4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed.
The Technical documentation shall include the elements set out in Annexes II and III.
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section2 of Annex XIII.
6. Where compliance with applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom made or investigational devices, shall draw up an EU Declaration of Conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.
7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.
8. Manufacturers shall keep the technical documentation, the EU Declaration of Conformity and, if applicable, a copy of any relevant certificate, including any amendments, and supplements, issued in accordance with Article 56, available for the Competent Authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Upon request by the competent authority, the manufacturer shall, as indicated therein, provide the technical documentation in its entirety or a summary thereof.
A manufacturer with a registered place of business outside the Union shall, in order to allow its authorized representative to fulfill the tasks mentioned in Article 11 (3) ensure that the authorized representative has the necessary documentation permanently available.
9. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation.
Changes in device design or characteristics and changes in the harmonized standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.
Manufacturers of devices, other investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
The quality management system shall cover all parts and elements of a manufacturer’s organization dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this regulation.
The quality management system shall address at least the following aspects:
(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
(b) identification of applicable general safety and performance requirements and exploration of options to address these requirements;
(c) responsibility of the management;
(d) resource management, including selection and control of suppliers and sub-contractors;
(e) risk management as set out in Section 3 of Annex I;
(f) clinical evaluation in accordance with Article 61 and Annexes XIV, including PMCF;
(g) product realization, including planning, design, development, production and service provision;
(h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and insuring consistency of information provided in accordance with Article 29;
(i) setting-up, implementation and maintenance of a post-market surveillance system in accordance with Article 83.
(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
(k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
(l) management of corrective and preventive actions and verifications of their effectiveness; and
(m) processes for monitoring and measurement of output, data analysis and product improvement.
10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.
11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an Official Union language(s) determined by the member State in which the device is made available to the user or patient.
The particulars on the label shall be indelible, easily legible, clearly comprehensible to the intended use or patient.
12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributor of the device in question and, where applicable, the authorized representative.
Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.
13. Manufacturers shall have a system of recording and reporting of incidents and field safety corrective action as described in Article 87 and 88.
14. Manufacturer shall upon request by a Competent Authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official EU language determined by the member state concerned.
The competent authority of the member state in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device, manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.
If the manufacturer fails to cooperate or the information and documentation is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device’s being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.
If a competent authority considers or has reason to believe that a device has caused damage, it shall upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user, as appropriate, the patient’s or user’s successor in title, the patient’s or user’s health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt within the context of legal proceedings.
15. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).
16. Natural or legal persons may claim compensation caused by a defective device in accordance with applicable EU and national law. (In other words: adequate Product Liability insurance is obliged!)
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under directive 85/374/EEC, without prejudice to more protective measures under national law.
As professional EU Authorized Representative service provider we’re looking forward to support you in your efforts to be in compliance with the EU regulatory requirements! Please contact us.