1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
summaries of the results of the surveillance activities referred to inArticle 93(4);
the final inspection report referred to in Article 93(7);
information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);
information in relation to non-compliance of products as referred to in Article 97(2);
information in relation to the preventive health protection measures referred to in Article 98(2);
summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in 93(8).
2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible to the Member States and to the Commission.
3. Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.
1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints.
2. The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local circumstances.
3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities’ activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and
shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users.
4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 100.
5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health.
6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions needed.
7. The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments. That final inspection report shall be entered in the electronic system provided for in Article 100.
8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 100.
9. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States.
Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation.
10. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.
11. Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.
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:
the devices are not transferred to another legal entity,
manufacture and use of the devices occur under appropriate quality management systems,
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,
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;
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,
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;
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
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).
Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services
Manage Cookie Consent
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.