The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:
(a)
the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
(b)
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
(c)
the transfer of documents, including confidentiality aspects and property rights;
(d)
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
2. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
(a)
verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
(b)
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c)
comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
(d)
in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
(e)
forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
(f)
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g)
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
(h)
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer’s obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
6. An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
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 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 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.
1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.
3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).
References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.
2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by:
(a)
ascribing functions and properties to the device which the device does not have;
(b)
creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c)
failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d)
suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.
1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation.
2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation.
3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.
4. A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity.
1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
4. Devices that are manufactured and used within health institutions shall be considered as having been put into service.
5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
(a)
the devices are not transferred to another legal entity,
(b)
manufacture and use of the devices occur under appropriate quality management systems,
(c)
the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,
(d)
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
(e)
the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution; (ii) the details necessary to identify the devices; (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
(f)
the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
(g)
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and
(h)
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an industrial scale.
6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Cases in which obligations of manufacturers apply to importers, distributors or other persons
1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a)
makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b)
changes the intended purpose of a device already placed on the market or put into service;
(c)
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a)
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b)
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (36) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a)
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b)
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c)
the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d)
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e)
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
(a)
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b)
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
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