the devices are not transferred to another legal entity;

manufacture and use of the devices occur under appropriate quality management systems;

the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation;

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:

as regards class D devices in accordance with the rules set out in Annex VIII, 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. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;

the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and

the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;

the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;

where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.

the device has been CE marked and the EU declaration of conformity of the device has been drawn up;

the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10);

for imported devices, the importer has complied with the requirements set out in Article 13(3);

that, where applicable, a UDI has been assigned by the manufacturer.

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 in vitro diagnostic medical devices;

four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

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;

the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

the post-market surveillance obligations are complied with in accordance with Article 10(9);

the reporting obligations referred to in Articles 82 to 86 are fulfilled;

in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.

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 in vitro diagnostic medical devices;

four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

makes available on the market a device under its own 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;

changes the intended purpose of a device already placed on the market or put into service;

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.

provision, including translation, of the information supplied by the manufacturer, in accordance with Section 20 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;

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.

any economic operator to whom they have directly supplied a device;

any economic operator who has directly supplied them with a device;

any health institution or healthcare professional to which they have directly supplied a device.

production of a UDI that comprises the following:

placing of the UDI on the label of the device or on its packaging;

storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 respectively;

establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28 of Regulation (EU) 2017/745.

the entity is an organisation with legal personality;

its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;

its system for the assignment of UDIs conforms to the relevant international standards;

the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;

the entity undertakes to do the following:

amending the list of information set out in Part B of Annex VI in the light of technical progress; and

amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.

determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;

specifying the data to be included in the UDI-PI of specific devices or device groups.

confidentiality and data protection as referred to in Articles 102 and 103 respectively;

the risk-based approach;

the cost-effectiveness of the measures;

the convergence of UDI systems developed at international level;

the need to avoid duplications in the UDI system;

the needs of the health care systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.

the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;

the intended purpose of the device and any indications, contra-indications and target populations;

a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;

reference to any harmonised standards and CS applied;

the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;

the metrological traceability of assigned values;

suggested profile and training for users;

information on any residual risks and any undesirable effects, warnings and precautions.

the electronic system for registration of devices referred to in Article 26;

the UDI database referred to in Article 25;

the electronic system on registration of economic operators referred to in Article 27;

the electronic system on notified bodies and on certificates referred to in Article 52;

the electronic system on performance studies referred to in Article 69,

the electronic system on vigilance and post-market surveillance referred to in Article 87;

the electronic system on market surveillance referred to in Article 95.

assess the impact on the certificates issued by the notified body;

submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;

require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;

enter in the electronic system referred to in Article 52 information in relation to certificates of which it has required their suspension or withdrawal;

inform the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.

the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or

the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor, and remain responsible for, existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.

where the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and

another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation.

development of best practice documents relating to the activities of the authorities responsible for notified bodies;

development of guidance documents for notified bodies in relation to the implementation of this Regulation;

training and qualification of the experts referred to in Article 36;

monitoring of trends relating to changes to notified body designations and notifications, and trends in certificate withdrawals and transfers between notified bodies;

monitoring of the application and applicability of scope codes referred to in Article 38(13);

development of a mechanism for peer reviews between authorities and the Commission;

methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.

scientific validity;

analytical performance;

clinical performance.

in which surgically invasive sample-taking is done only for the purpose of the performance study;

that is an interventional clinical performance study as defined in point (46) of Article 2; or

where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,

the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated;

an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law;

the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;

vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;

the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;

the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59;

the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;

the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;

the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored;

the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions;

no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study;

where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted;

in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art;

in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;

the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention;

the requirements of Annex XIV are fulfilled.

enable the subject or his or her legally designated representative to understand:

be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;

be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and

include information about the applicable damage compensation system referred to in Article 65;

include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article.

the informed consent of their legally designated representative has been obtained;

the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it;

the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;

no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;

the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;

the performance study relates directly to a medical condition from which the subject suffers;

there are scientific grounds for expecting that participation in the performance study will produce:

the informed consent of their legally designated representative has been obtained;

the minors have received the information referred to in Article 59(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;

the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;

no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;

the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;

the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;

there are scientific grounds for expecting that participation in the performance study will produce:

the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;

if during a performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study.

due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study;

there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;

it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;

the investigator certifies that he or she is not aware of any objections to participate in the performance study previously expressed by the subject;

the performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations;

the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.

regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative;

regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.

in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study;

in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts.

the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art;

whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards;

whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate;

the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints;

whether the requirements of Annex XIV are met.

the application dossier submitted pursuant to Article 66(3) remains incomplete;

the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients;

the requirements of Article 58 are not met; or

any assessment under paragraph 3 is negative.

the objective and methodology of the performance study; and

the degree of deviation of the intervention from normal clinical practice.

to create the single identification numbers for performance studies referred to in Article 66(1);

to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;

for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74;

for information to be provided by the sponsor in accordance with Article 73, including the performance study report and its summary as required in paragraph 5 of that Article;

for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76.

protection of personal data in accordance with Regulation (EC) No 45/2001;

protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure;

effective supervision of the conduct of the performance study by the Member State(s) concerned.

the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or

an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State.

revoke the authorisation for the performance study;

suspend or terminate the performance study;

require the sponsor to modify any aspect of the performance study.

within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);

for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;

within 10 days of the notification date, assess whether the performance study falls within the scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;

establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.

any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;

any serious adverse event;

any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

any new findings in relation to any event referred to in points (a) to (c).

any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible;

any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

any new findings in relation to any event referred to in points (a) and (b).

to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);

to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI;

to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation;

to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices;

to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks;

to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance;

to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures;

to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order;

to contribute to the development of CS and of international standards;

to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality.

have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated;

possess the necessary equipment and reference material to carry out the tasks assigned to them;

have the necessary knowledge of international standards and best practices;

have an appropriate administrative organisation and structure;

ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks;

act in the public interest and in an independent manner;

ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs.

applying coordinated methods, procedures and processes;

agreeing on the use of same reference materials and common test samples and seroconversion panels;

establishing common assessment and interpretation criteria;

using common testing protocols and assessing the test results using standardised and coordinated evaluation methods;

using standardised and coordinated test reports;

developing, applying and maintaining a peer review system;

organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results);

agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures;

coordinating the introduction of testing methods for new technologies and according to new or amended CS;

reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission.

detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article.

the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness.

personal data in accordance with Article 103;

commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights unless disclosure is in the public interest;

the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.

31 December 2027, for class D devices;

31 December 2028, for class C devices;

31 December 2029, for class B devices and for class A devices placed on the market in sterile condition.

those devices continue to comply with Directive 98/79/EC;

there are no significant changes in the design and intended purpose;

the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8);

the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, no later than:

the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII no later than:

Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;

Article 97 shall apply from 26 May 2018;

Article 100 shall apply from 25 November 2020;

for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;

►M4  without prejudice to the obligations of the Commission pursuant to Article 34 of Regulation (EU) 2017/745, the obligations and requirements that relate to any of the electronic systems referred to in Article 30(2) of this Regulation shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1) of that Regulation. The provisions referred to in the preceding sentence are: ◄

▼M4

▼B

▼M4

▼B

▼M4

Until the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directive 98/79/EC regarding information on vigilance reporting, performance studies, registration of devices and economic operators, and certificate notifications shall continue to apply.

no later than 6 months from the date set out in point (f), first subparagraph, of this paragraph, manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 26 is entered in the electronic system referred to in Article 30(2), points (a) and (b), including regarding the following devices, provided that those devices are also placed on the market from the date set out in point (f), first subparagraph, of this paragraph:

no later than 12 months from the date set out in point (f), first subparagraph, of this paragraph, notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 51(5) is entered in the electronic system referred to in Article 30(2), point (d), including regarding devices referred to in point (fa)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered;

by way of derogation from point (f), first subparagraph, of this paragraph, the obligations to upload the summary of safety and performance in accordance with Article 29(1) and to notify competent authorities in accordance with Article 50(1), through the electronic system referred in Article 30(2), point (d), shall apply to devices referred to in point (fa) of this paragraph when the certificate is entered in Eudamed in accordance with point (fb) of this paragraph;

without prejudice to point (f), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 81(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 82 of this Regulation, or to submit a trend report in accordance with Article 83 of this Regulation through the electronic system referred to in Article 30(2), point (f), of this Regulation, it shall also register the device, which is the subject of the PSUR or the vigilance reporting, in the electronic system referred to in Article 30(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 98/79/EC;

Article 110(10) shall apply from 26 May 2019;

Article 5(5), points (b) and (c) and (e) to (i), shall apply from 26 May 2024;

Article 5(5), point (d), shall apply from ►M4  31 December 2030 ◄ .