Explanatory Memorandum to COM(2024)43 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices

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dossier COM(2024)43 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in ...
source COM(2024)43
date 23-01-2024


1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Regulation (EU) 2017/745 (the ‘Medical Devices Regulation’ (MDR))0 and Regulation (EU) 2017/746 (the ‘In Vitro Diagnostic Medical Devices Regulation’ (IVDR))0 of the European Parliament and of the Council set a strengthened regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs). Their objectives are a high level of protection of health for patients and users and the smooth functioning of the single market for these products. To achieve these objectives and to address issues identified with the previous regulatory framework, the Regulations set up a more robust system of conformity assessment to ensure the quality, safety and performance of devices placed on the EU market.

The MDR has applied since 26 May 20210. The transitional period provided for in Article 120 has been extended by Regulation (EU) 2023/6070 and will end on either 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions.

The IVDR has applied since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transitional period, ranging from 26 May 2025 for high-risk IVDs to 26 May 2027 for lower-risk IVDs, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions0. This extension was not subject to conditions similar to the ones laid down for medical devices by Regulation (EU) 2023/607.

This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.

Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices.

In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs.

a) Transition of devices to the IVDR

There is a wide variety of IVDs, including HIV tests for blood donation screening or individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two thirds of all clinical decisions are based on information provided by IVDs0. It is paramount to ensure both a high level of safety and performance of IVDs and their availability to healthcare systems.

The IVDR has introduced very substantial changes to the regulatory framework for IVDs with significant resource and capacity implications. According to the IVDR, IVDs are classified into different risk classes from class A (low risk) to class D (high risk). One of the most profound changes is the increased involvement of independent conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way that is proportionate to the device’s risk class. Under the previous Directive 98/79/EC0, only a relatively small number of high-risk devices, i.e. about 8% of the more than 40 000 IVDs on the EU market covered by the Directive0, were subject to scrutiny by notified bodies. In October 2022, there were 1 551 valid certificates issued by notified bodies under Directive 98/79/EC0. Some of these have already expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 certificates will expire in 2025 (by 26 May)0.

Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, most of them for the first time8. As a consequence, the number of certificates under the IVDR is expected to be significantly higher than the number of certificates issued under Directive 98/79/EC. The relationship between the number of devices and the number of certificates covering them is complex, so no precise calculation can be made, but numbers in the order of 15 000 certificates and higher could reasonably be expected. More than 1 000 devices are in the highest risk class (class D)0. Under the IVDR, these devices require the issuance of both a quality management system certificate and an individual device technical documentation assessment certificate.

Those figures are in stark contrast to the low number of certificates already issued and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not yet transitioned to the IVDR. As of end of October 2023, manufacturers had submitted 1 378 applications for conformity assessment under the IVDR, resulting in 677 certificates issued by notified bodies across all risk classes. For class D IVDs, only 335 applications had been submitted and 117 certificates had been issued0.

While there are still several years of transitional period remaining for classes C, B and A sterile, the transitional period for class D devices ends on 26 May 2025. Given the low number of certificates and applications for class D IVDs, and the long duration of the conformity assessment process as explained below, there is a high risk of shortages of many of these devices. Class D devices are used, for example, to test for infections in blood or organ donations, to test patients for life-threatening infectious diseases, or for blood grouping for transfusions. Therefore, there is a high risk of a public health crisis if there is a shortage of such devices.

As explained above, in January 2022, the European Parliament and the Council adopted a staggered extension of the transitional period due to the impact of the COVID-19 pandemic. The slow rate of transition has made this extension insufficient. The reasons are multifaceted; however, they are underpinned by the far‑reaching nature of changes introduced by the IVDR and the resulting increased need for scientific, technical and regulatory expertise and capacity at all levels in the system, which require time to be built up.

At present, only 12 notified bodies0 are designated under the IVDR, compared to 22 notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal from the EU). A further 8 applications for designation as notified body are currently in progress. The staggering of the transitional periods by risk class in 2022 meant that the workload on notified bodies could be distributed over time, and provided relief to the sector0. Nevertheless, access to notified bodies has remained an issue, especially for small to medium-sized enterprises (SMEs)11.

Notified bodies are also facing challenges due to the extensive changes introduced by the IVDR. They must apply new requirements for types of devices that they have not handled previously. The duration of the notified body’s assessment is affected by the often insufficient quality of manufacturers’ applications0. As of July 2023, the average duration of the conformity assessment process combining quality management system and technical documentation assessment was around 18 months15.

Thus, the overall notified body capacity in the EU is limited, due to both low numbers of notified bodies and challenges to their efficient and smooth operation. Additional transition time is needed to help address this persisting problem. More notified bodies will be designated over time and the efficiency in processing applications will improve as both manufacturers and notified bodies gain more experience with the IVDR. In the short term, it is also important to maintain the staggering of transitional periods by risk class to avoid a bottleneck at the level of notified bodies.

Furthermore, it appears that many manufacturers are not sufficiently prepared to demonstrate compliance with the requirements of the IVDR. This may be due to various causes, including the complexity of these new requirements, lack of experience of interaction with notified bodies, and the continuous development of the IVDR framework, such as ongoing designation of notified bodies, and for class D IVDs adoption of common specifications and designation of EU reference laboratories. Around 90% of medical device companies are SMEs0, for which managing the transition can be especially challenging. More and more tools are being put in place to support manufacturers, with particular attention to SMEs, including: (i) guidance by the Medical Device Coordination Group (MDCG) and by notified bodies; (ii) webinars and training by notified bodies; (iii) structured dialogue with notified bodies0; or (iv) EU-funded work to make notified body capacity more visible0. Additional transition time is necessary to allow manufacturers to make greater use of these tools and therefore support the transition of their devices to the IVDR.

This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements.

The need for additional time is most acute for mitigating shortages of class D devices. They constitute about 4% of the market16 but their conformity assessment is intensive due to the requirement for individual technical documentation assessment and, where relevant, involvement of the scientific bodies (expert panel and EU reference laboratories). With only 12 notified bodies currently designated, capacity in the system to perform the required third party assessments remains limited, so an extension of the transitional period for class D IVDs should be combined with a shift in the transition deadlines for the other device groups as well to avoid a bottleneck in the certification process and to prevent shortages of these devices too. Class C and class B are large device groups (representing 26% and 49% of the market, respectively), and some of them are also subject to special requirements such as individual technical documentation assessment. It is also logical from the perspective of protection of public health that higher risk classes should be subject to the more stringent rules earlier than lower risk classes.

The extension should be subject to conditions to support the transition to the IVDR, similar to the approach adopted in Regulation (EU) 2023/607, which extended the MDR transitional period. These conditions will ensure that only manufacturers that are actively taking the necessary steps to transition to the new rules and continue to place on the market devices meeting high safety standards will benefit from the additional time. In addition, at the latest by 26 May 2025, all manufacturers will have to put in place a quality management system in accordance with Article 10(8) IVDR. Such an approach respects the work of those manufacturers that have already taken the necessary steps to comply with the IVDR.

Finally, it is clear that an extension of the transitional period will provide only a short-term solution to mitigate the risk of shortages. It will not solve certain underlying structural problems related to the implementation of the IVDR, notably with regard to the specific situation of SMEs. Moreover, the transition must be completed to ensure the credibility and robustness of the EU medical device regulatory system and to provide the necessary legal certainty for a stable, innovative and safe environment. It is necessary to analyse problems related to the implementation of the IVDR and the MDR, and their root causes, to identify shortcomings of the regulatory framework and remedy them in the medium term with a view to ensuring patient safety and access to safe and performant devices in a sustainable manner.

b) European database on medical devices (Eudamed)

In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set up, maintain and manage the European database on medical devices (Eudamed). Eudamed must include seven electronic systems including the UDI database0. It is being developed in accordance with functional specifications drawn up by the Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant to these specifications, Eudamed will consist of six modules0, covering all the features specified by the Regulations: UDI/Devices, Actors, Notified bodies/Certificates, Post-Market Surveillance and Vigilance, Market Surveillance, and Clinical investigations/Performance studies.

Three Eudamed modules have been available for voluntary use since December 2020 (Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further modules (Market Surveillance; Post-Market Surveillance and Vigilance) are expected to be completed in Q2/2024. The last module (Clinical investigations/Performance studies) will not be completed before Q3/2026. Pursuant to the current MDR rules, Eudamed can only be used mandatorily from a certain date after the Commission has verified that Eudamed is fully functional and has published a notice to that effect. Therefore, the delayed development of the last module holds back the mandatory use of the electronic systems that have been completed already. The mandatory use of all six modules thus cannot be expected before Q4/2027, with additional transitional periods not ending before Q2/2029.


However, the use of Eudamed is key for effective and efficient implementation of the MDR and IVDR and of high value to the work of the competent authorities and the Commission in monitoring the market. Moreover, the deployment of Eudamed has profound and beneficial implications in terms of resource savings for manufacturers as it prevents multiple registrations or instances of communication of data at national level. This proposal aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025. Consequently, also the specific transitional provisions in the MDR and IVDR related to Eudamed need to be amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed.

In addition, having regard to the delay in the development of the module for clinical investigations / performance studies, the timelines for the application of the coordinated assessment of clinical investigations and performance studies need to be adapted. Keeping the approach provided for in the MDR and the IVDR, the coordinated assessment should first be applied by Member States on an ‘opt-in’ basis. Five years after its voluntary application, the coordinated assessment should become mandatory for all Member States.

c) Prior notice if supply of certain medical devices and in vitro diagnostic medical devices is stopped

Healthcare professionals, industry and competent authorities have reported that during the transitional period of the MDR and the IVDR, the supply of many medical devices and IVDs has or is likely to be stopped. In certain cases, especially if no or few alternative devices are available, the interruption of supply can result in serious harm or a risk of serious harm to patients or public health.

This proposal aims to impose an obligation on manufacturers to inform their relevant competent authority and health institutions before they cease, temporarily or permanently, the supply of a critical device. If manufacturers do not supply directly to health institutions or healthcare professionals, they should inform the relevant economic operators in the supply chain, which then can inform the health institutions. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety. In accordance with Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure effective and harmonised implementation of this prior notice mechanism.

• Consistency with existing policy provisions in the policy area

The proposal is consistent with existing policy provisions as well as ongoing non‑legislative measures, which will supplement the proposed amendment. To avert the risk of shortages of medical devices, the European Parliament and the Council adopted in March 2023 Regulation (EU) 2023/6070 extending the MDR transitional period until 31 December 2027 or 31 December 2028, depending on the device’s risk class and subject to certain conditions. On 25 August 2022, the MDCG endorsed its position paper MDCG 2022-140. The paper sets out 19 non-legislative measures with a view to increasing notified body capacity, access to notified bodies, and manufacturers’ preparedness. This should support a successful transition to the MDR and IVDR. Several of the measures listed in MDCG 2022-14 have already been implemented, such as a MDCG position paper on hybrid audits0, new MDCG guidance on appropriate surveillance0, and a revision of MDCG 2019-6, removing obstacles to the employment of qualified personnel by notified bodies0.

On 1 December 2022, the Commission adopted two delegated acts deferring the first complete reassessment of notified bodies0. This has freed up capacity of both designating authorities and notified bodies.

Work is ongoing to implement the remaining measures listed in MDCG 2022-14, as they remain important also under an extended transitional period. Measures to support the implementation of the two Regulations are regularly (co-)funded under annual work programmes of the EU4Health Programme0. Among other measures, in April 2023, the Commission has ordered a study on regulatory governance and innovation, which should provide preliminary results in Q3/2024.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

The proposal is based on Article 114 and Article 168 i, point (c), of the Treaty on the Functioning of the European Union (TFEU).

• Subsidiarity (for non-exclusive competence)

According to the principle of subsidiarity, EU action may only be taken if the aims of the envisaged measure cannot be achieved by Member States alone. The legislation being amended was adopted at EU level in line with the subsidiarity principle and any amendment must be made through an act adopted by the EU legislators. As regards the current proposal for an amendment, EU action is required to: (i) avoid any potential disruption in the supply of IVDs; (ii) enable timely use of completed Eudamed modules; (iii) ensure the smooth functioning of the single market; and (iv) ensure a high level of health protection for patients and users.

• Proportionality

The proposed EU action is necessary to mitigate the risk of shortages of IVDs across the EU and the serious impact of such shortages on public health. The proposed targeted amendments thus aim to help achieve the intended purpose of the MDR and the IVDR. This purpose is to set a robust, transparent, predictable and sustainable regulatory framework for medical devices and IVDs that guarantees a high level of protection of public health and patient safety and the smooth functioning of the single market for these products.

The proposal maintains the objective of the IVDR to ensure a high level of safety and performance of devices by strengthening their scrutiny by notified bodies. It provides the additional time needed to build the necessary capacity and expertise to achieve this objective, while safeguarding a high level of protection of public health and patient safety.

The proposal is proportionate in that it aims to address the identified issue, i.e. that due to shortage of notified body capacity and insufficient preparedness among manufacturers, a large number of existing IVDs may disappear from the market. Therefore, the proposed amendments to the IVDR are limited to enabling a gradual implementation of the requirements, limited to ‘legacy’ devices0 that require notified body involvement in the conformity assessment, without changing the substance of these requirements. In addition, the extension of the transitional period is subject to conditions that set milestones for manufacturers and help them and notified bodies structure the transition. The Commission proposes to differentiate between higher‑risk devices (i.e. class D) and medium- to lower-risk devices (i.e. class C, class B and class A sterile), with shorter transitional periods for higher-risk devices and longer periods for lower-risk ones. This approach aims to balance the available notified body capacity and manufacturers’ level of preparedness with a high level of public health protection.

As regards Eudamed, the proposal is proportionate as it enables faster achievement of the objective to increase transparency of the regulatory system.

• Choice of the instrument

The proposed act is a Regulation to be adopted by the European Parliament and the Council, given that the acts to be amended are Regulations adopted by the European Parliament and the Council.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Ex post evaluations / fitness checks of existing legislation

Given the urgent nature of this proposal and the limited changes related only to the gradual roll-out of Eudamed and the extension of the IVDR transitional period, it is not accompanied by a dedicated impact assessment. An impact assessment was already carried out when preparing the proposals for the MDR and the IVDR, and this proposal does not alter the MDR or IVDR in substance and does not impose new obligations on the concerned parties. It primarily aims to amend the transitional provisions, giving, under certain conditions, additional time to transition to the IVDR’s requirements to avoid shortages and protect public health in the EU. By enabling an earlier mandatory use of available Eudamed modules, sometimes multiple national registrations or notifications will be replaced by a single registration/notification at EU level. The proposal will also increase transparency and traceability of medical devices and IVDs, facilitating monitoring of their availability and their safe performance by national competent authorities via EU-wide electronic means. The need to act quickly to ensure certainty ahead of the end of the IVDR’s current transitional period made it impossible to carry out a broad public consultation. Therefore, the Commission collected the necessary input from Member States and stakeholders through targeted exchanges.

Input from Member State authorities and stakeholders has been sought through targeted interaction, mainly during the MDCG meetings on 10-11 October and 11-12 and 18 December 2023 and related discussions in MDCG subgroups. An extraordinary MDCG meeting with stakeholders was held on 20 December 2023 to discuss issues related to possible amendments. An exchange of views with Member States took place on 30 November 2023 during the EPSCO Health Council.

The Commission will continue to closely monitor the progress in the implementation of the Regulations and the impact of the proposed amendments. It will also consult with the MDCG and stakeholders about the need for supplementary action.

In accordance with Article 121 MDR and Article 111 IVDR, the Commission is required to assess the application of the Regulations and produce an evaluation report at the latest by 27 May 2027. Having regard to the multiple challenges related to the implementation of the two Regulations, the Commission will start preparatory works for a targeted evaluation already in 2024. The targeted evaluation will assess in particular whether the legislation has delivered results as intended, and whether it is (still) fit for purpose or underperforming in ensuring availability of devices for small patient populations (i.e. ‘orphan devices’) and fostering the development and availability of innovative devices in the EU. The implementation of the prior notice mechanism for monitoring device shortages will deserve special attention in the assessment, as well as costs and administrative burdens stemming from the implementation of the legislation, especially for SMEs.

4. BUDGETARY IMPLICATIONS

Contents

1.

The proposed action has no budgetary implications


5. OTHER ELEMENTS

• Detailed explanation of the specific provisions of the proposal

Article 1: amendments to the MDR

Article 1 introduces a new Article 10a laying down an obligation on manufacturers to give prior notice about interruption of supply of certain critical medical devices. Besides notification to the relevant competent authorities, manufacturers should also inform health institutions or healthcare professionals and economic operators to whom the directly supply the device. The relevant economic operators should provide the information in the downstream supply chain until it reaches the health institutions or healthcare professionals. This mechanism will enable the authority and health institutions to consider mitigating measures to ensure patient health and safety.

It also amends several provisions related to Eudamed. The changes to Article 34(1) and (2) remove the concept that the use of Eudamed can only become mandatory when all its modules have been declared fully functional. Instead, the new wording of the provisions enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional.

As the application of the coordinated assessment of clinical investigations depend on the functionality of the Eudamed module on clinical investigations / performance studies, the timeline for the application of the coordinated assessment has been adapted in Article 78(14). The approach is kept that the coordinated assessment procedure should, during the first five years, apply only to Member States on an ‘opt-in’ basis, before it will become mandatory for all Member States.

Consequently, also the specific transitional provisions in Article 120(8), Article 122 and Article 123(3) related to Eudamed are amended to enable a smooth progressive transfer from multiple registrations in national databases to a single registration in Eudamed. The amendments make sure that national registration requirements end when the registration requirements in Eudamed start to apply. Moreover, the changes clarify which devices and which certificates must be registered in Eudamed and in which timeframe.

Article 2: amendments to the IVDR

Article 2 contains the amendments to the IVDR, which mirror to a large extend the changes made to the MDR. A new Article 10a provides for a prior notice mechanism when a manufacturer anticipates the interruption of supply of certain critical in vitro diagnostic medical devices. The provisions concerning the timing of the application of the coordinated assessment of performance studies (Article 74(14)) and the specific transitional provisions related to Eudamed in Article 110(8), Article 112 and Article 113(3) are amended in a similar way as it is done in the MDR.

In addition, Article 110(2) and (3) are amended to extend the IVDR’s transitional periods. For that purpose, the changes in Article 110(2) extend the validity of certificates issued under Directives 98/79/EC that were valid on the day of the IVDR’s date of application (26 May 2022) and have not been withdrawn by a notified body. The extension is directly applicable, so that notified bodies are not required to change the date on the individual certificates. The length of the extension of the certificate’s validity corresponds to the length of the extended transitional period laid down in the proposed Article 110(3) to (3b). As regards certificates that have already expired when the proposed amendment comes into force, the extension will be subject to the condition that, at the moment of the expiry, the manufacturer has signed a contract with a notified body for the conformity assessment of the device in question. Alternatively, if no such contract has been signed at the moment when the certificate expired, a national competent authority may have granted a derogation from the applicable conformity assessment procedure in accordance with Article 54 or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 92.

The changes to Article 110(3) extend the transitional periods that are applicable to ‘legacy devices’, i.e. those covered by a certificate or declaration of conformity issued under Directive 98/79/EC before 26 May 2022. Due to the length of the provision, paragraph 3 is replaced by paragraphs 3 to 3e. The staggering of the transition periods is kept, extending the timeline until 31 December 2027 for IVDs covered by a certificate that was issued in accordance with Directive 98/79/EC and for class D devices, until 31 December 2028 for class C devices and until 31 December 2029 for class B and A sterile devices.

2.

Moreover, the application of the extended transition period is subject to several cumulative conditions, which are:


○ the devices must continue to comply with Directive 98/79/EC. This condition is already part of the current Article 110(3);

○ the devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 110(3);

○ 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. The concept of “unacceptable risk to health and safety” is set out in Article 89 and 90 of the IVDR. No systematic check of the device’s safety is required, as devices covered by a certificate issued under Directive 98/79/EC will be under ‘appropriate surveillance’ by the body that issued the certificate or a notified body designated under the IVDR. Where, as part of their market surveillance activities, a competent authority finds that a device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the transition period ceases to apply for that device;

○ no later than 26 May 2025, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(8) of the IVDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the IVDR requirements. No specific attestation, i.e. no self-declaration nor verification of the appropriateness of the QMS by a notified body, is required at this stage;

○ by a specific date (26 May 2025, 26 May 2026 or 26 May 2027, depending on the risk class), the manufacturer, or its authorised representative, has lodged a formal application in accordance with Annex VII, Section 4.3, of the IVDR for conformity assessment in respect of the ‘legacy device’ covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the IVDR. Within four months, such an application must be covered by a written agreement between the notified body and the manufacturer. This condition aims to ensure that only devices that the manufacturer intends to transition to the IVDR will benefit from the extended transition period. The extension should, however, also apply to ‘legacy devices’ that the manufacturer intends to replace by a ‘new’ device for which it applies for conformity assessment before the relevant deadline set in Article 110(3c). In this way, unnecessary applications for certification of devices that will in any case be phased out and replaced by a new generation of devices will be avoided, whist keeping the existing models available until the end of the transition period.

The devices covered by a certificate issued under Directive 98/79/EC remain subject to ‘appropriate surveillance’ by the notified body that issued the certificate. Alternatively, the manufacturer can agree with a notified body designated under the IVDR that the latter becomes responsible for the surveillance. At the latest by the date when the written agreement between the manufacturer and the notified body for conformity assessment in accordance with the IVDR needs to be signed, that notified body would by default become responsible for the appropriate surveillance.

Article 3: entry into force

Article 3 provides for the entry into force of the Regulation on the date of its publication and a deferred application of the prior notice mechanism.