General obligations of manufacturers
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 Section 2 of Annex XIII.
6. Where compliance with the 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 a competent authority, the manufacturer shall, as indicated therein, provide that 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 authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised 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 harmonised 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 than 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 organisation 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 those
(c) responsibility of the management;
(d) resource management, including selection and control of suppliers and sub-contractors;
(e) risk management as set out in in Section 3 of Annex I;
(f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
(g) product realisation, 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 ensuring
consistency and validity 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 verification of their effectiveness;
(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 and clearly comprehensible to the intended user 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 distributors of the device in question and, where applicable, the authorised representative and importers accordingly.
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 for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.
14. Manufacturers 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 Union 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 provided 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 and, 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 with in 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 for damage caused by a defective device in accordance with applicable Union and national law.
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.
Article 10 is a substantial article of the MDR, and it includes a lot of requirements. The requirements are applicable to ALL manufacturers, regardless of which classification the medical device happens to have. The focus of this commentary text is not on the QMS requirements (as found in section 9 a-m above) but on the rest.
The first obligation, which might be obvious, is that manufacturers need to meet the requirement that their devices have must been designed and manufactured in accordance with the requirements of the MDR.
The next obligation is related to risk management. Manufacturers must establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. And Annex I is where you will find the general safety and performance requirements, GSPRs.
The GSPRs are the requirements that apply to all medical device manufacturers in relation to safety and performance. A well-functioning risk management system is one of the most important things to implement when working with medical devices.
The following obligation relates to clinical evaluation and post-market clinical follow-up, or just short PMCF. All manufacturers must conduct a clinical evaluation per Article 61 and Annex 14, including PMCF. The clinical evaluation must be done before putting a device on the market. And then, PMCF is the maintenance activity of that clinical evaluation when the device is on the market.
Then there is a critical requirement that is important to those involved in developing new medical device products. Manufacturers must draw up the technical documentation for the medical device and keep it up to date. This technical documentation must be prepared in a way that allows assessment by a third party to confirm the conformity of the device to the MDR requirements. The technical documentation must include the elements in Annexes II and III, which are the annexes for the content of the technical documentation for the product and the technical documentation requirements of the post-market surveillance system, the PMS.
It is not only the technical documentation that the manufacturers shall keep updated. The EU declaration of conformity and, if applicable, a copy of any relevant notified body certificate, including amendments and any updates must also be kept up to date and available for the competent authorities for a period of at least 10 years after the last device has been placed on the market. And for implantable devices, this period shall be at least 15 years.
Furthermore, manufacturers must draw up an EU declaration of conformity in accordance with Article 19, and also affix the CE mark of conformity in accordance with Article 20 BEFORE they release products to the market. This is the manufacturer’s way of showing the users that their devices are in conformity with the MDR requirements.
Then there are the obligations relating to UDI. Manufacturers must comply with the obligations relating to the UDI system referred to in Article 27 and the registration obligations referred to in Articles 29 and 31, which is EUDAMED. In summary, the manufacturer must register all their devices with corresponding UDI in EUDAMED.
Furthermore, manufacturers shall ensure that procedures within their QMS are in place to keep serial production in conformity with the requirements of the MDR. Potential changes in device design or characteristics must be managed in a controlled way. And if any harmonised standards or CS (Common Specification) are referenced by the manufacturer to fulfil conformity requirements are updated, this must be taken into account by the manufacturer in a timely manner.
Manufacturers must also implement and keep up-to-date a post-market surveillance system, a PMS, per Article 83. The PMS is where the manufacturer stays updated on their devices when they are on the market so they can act if needed.
Moreover, with some exceptions, manufacturers must ensure the medical device is delivered with instructions for use and labels in the official language of the country it is delivered to. This applies to all the information specified in Section 23 of Annex I, the general safety and performance requirements. If you read section 23 of Annex I, a long list of information is required to supply with the medical device, like on the label and/or in the instructions for use.
Another requirement mentioned in the MDR is that the data on the label shall be permanent, easily understandable and clearly logical to the intended user or patient. But the MDR uses the words “indelible, easily legible and clearly comprehensible”.
Manufacturers who consider or have reason to believe that a device is not in conformity with the MDR shall immediately take the necessary corrective actions to bring that device into conformity, to withdraw it or to recall it, as appropriate. The manufacturer must also inform the distributors of the device in question and, where applicable, the authorised representative and importers if needed. And where the device presents a serious risk, manufacturers must immediately inform the competent authorities of the member states in which they have made the device available and, where applicable, the notified body that issued the certificate for the medical device. Keep in mind, that if your medical device has been tested by a 3rd party for, as an example electrical safety, it may be stated in the contract with the test performer to also notify them if there should be a serious incident with your medical device. But that requirement is not in the MDR, so only potentially in your contract with that 3rd party test house.
Lastly, manufacturers must have a system for recording and reporting incidents and field safety corrective actions as described in Articles 87 and 88. And the collective term for these kinds of activities is vigilance.
Applicable MDCG guidance documents
Relevant blog posts
About the Author
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.