746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices - Main contents

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dossier	COM(2023)10 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices ...
source	COM(2023)10
date	06-01-2023

1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

Regulation (EU) 2017/745 (MDR) ¹ and Regulation (EU) 2017/746 (IVDR) ² of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.

The MDR has been applicable since 26 May 2021 ³ . The transition period provided for in Article 120(3) will end on 26 May 2024.

The IVDR has been applicable since 26 May 2022. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions ⁴ .

Despite considerable progress over the past years, the overall capacity of conformity assessment (‘notified’) bodies remains insufficient to carry out the tasks required of them. In addition, many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This is threatening the availability of medical devices on the EU market.

At present, 36 notified bodies are designated under Regulation (EU) 2017/745. Further 26 applications for designation as notified body are currently being processed; three of them are at an advanced stage ⁵ .

In October 2022, notified bodies reported they had received altogether 8,120 applications from manufacturers for certification under the MDR and had issued 1,990 certificates in accordance with the MDR. According to an estimation presented by notified bodies to the Medical Device Coordination Group (MDCG) ⁶ on 17 November 2022, the number of certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance remains the same with no changes to current conditions. Notified bodies estimate that the transition of all Directives’ certificates to MDR certificates could possibly be completed by December 2027 ⁷ .

Source: European Commission, based on data provided by 30 notified bodies in October 2022.

This is in stark contrast to 21,376 valid certificates issued under Council Directive 90/385/EEC on active implantable medical devices (AIMDD) ⁸ and Council Directive 93/42/EEC on medical devices (MDD) ⁹ that will expire between January 2023 and 26 May 2024. Of those 21,376 certificates, 4,311 certificates will expire in 2023 and 17,095 certificates will expire in the first five months of 2024. Of note, 3,509 certificates issued under the AIMDD or MDD have already expired between May 2021 and December 2022.

Year of expiry	Number of expired/expiring certificates issued under Council Directives 90/385/EEC and 93/42/EEC
2021 (from 26 May)	1,139
2022	2,370
2023	4,311
2024 (until 26 May 2024)	17,095

Source: European Commission, based on data provided by notified bodies in 2021 and 2022.

After the expiry of the certificates issued under the Directives and without a valid MDR certificate, manufacturers are no longer allowed to place these medical devices on the EU market. This may cause shortages of medical devices, putting patient safety at risk. It is also likely to have a significant negative impact on innovation and business activity in the medical technology sector within the EU. The situation is exacerbated by the impact of the COVID-19 pandemic on clinical investigations, on-site audits and global supply chains, on which Russia’s war of aggression against Ukraine is having a further negative impact.

The overall goal of the proposed amendments is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The extension will be staggered depending on the risk class of the device, i.e. until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices.

This proposal thus aims to extend the current transition period laid down in Article 120 of the MDR, based on certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time. This would give manufacturers and notified bodies more time to conduct the conformity assessment procedures in accordance with the MDR, if those conditions are fulfilled. It also proposes to delete the ‘sell-off’ deadline in the relevant MDR and IVDR provisions, i.e. the end date for the further making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the extended transition period is over. This would prevent unnecessary disposal of safe medical devices that are already on the market but not yet with the final user.

The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC for the devices benefiting from the extended transition period. Also the validity of certificates that have already expired since 26 May 2021 would be extended, subject to certain conditions.

• Consistency with existing policy provisions in the policy area

The proposal is coherent with existing policy provisions as well as on-going non-legislative actions, which will complement the proposed amendment. On 25 August 2022, the MDCG endorsed its position paper MDCG 2022-14 ¹⁰ . The paper lays out 19 non-legislative actions with a view to enhancing notified body capacity, access to notified bodies and manufacturers’ preparedness and thereby support a successful transition to the MDR and IVDR. Several of the actions listed in MDCG 2022-14 have already been implemented, such as a MDCG position paper on hybrid audits ¹¹ , new MDCG guidance on appropriate surveillance ¹² , and a revision of MDCG 2019-6, removing obstacles to the employment of qualified personnel by notified bodies ¹³ .

On 1 December 2022, the Commission adopted two delegated acts deferring the timing of the first complete re-assessment of notified bodies ¹⁴ . This is expected to free capacities both for designating authorities and notified bodies.

Work is ongoing to implement the remaining actions listed in MDCG 2022-14, as they remain important also if the transition period is extended.

Further actions to support implementation of the two Regulations are also (co-)funded under the 2022 and 2023 work programmes of the EU4Health Programme ¹⁵ .

On 9 December 2022, the MDCG issued its position paper MDCG 2022-18 ¹⁶ which sets out a uniform approach of competent authorities to applying market surveillance measures to bridge the gap between the expiry of MDD or AIMDD certificates and the issuance of MDR certificates. That approach is meant to be a temporary measure until the legislative changes in this proposal take effect. It contributes to avoiding disruption of supply of medical devices on the EU market. However, having regard to the number of certificates expiring in 2023 and 2024, it is not considered a sustainable solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

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

• Subsidiarity

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. In the case of the current proposal for an amendment, EU action is required to avoid disruption in the supply of devices across the EU, to ensure the smooth functioning of the internal market, and to ensure a high level of health protection for patients and users.

• Proportionality

The proposed EU action is necessary to avert the risk of shortages of medical devices across the EU. The proposed amendments aim to ensure that the intended purpose of the MDR and IVDR can be attained. That purpose is to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for these products. The proposal maintains the objective of both Regulations to ensure a high level of safety and performance of devices by enhancing their oversight by notified bodies. It only provides for the necessary additional time to achieve this objective. 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 devices may disappear from the market. Therefore, the proposed amendments to the MDR are limited to allowing a gradual phase-in of the requirements, limited to ‘legacy’ devices that need notified body involvement in the conformity assessment, without altering the substance of those requirements, and the deletion of the ‘sell-off’ deadline. The amendment of the IVDR is limited to the deletion of the ‘sell-off’ deadline in order to be consistent with the proposed change in the MDR. The Commission proposes to differentiate between higher risk devices (i.e. class III and class IIb implantable) and lower risk devices (i.e. other class IIb, class IIa and class Im, Is, Ir ¹⁷ ), with shorter transition periods for higher risk devices and longer periods for lower risk ones. This approach aims to balance the available notified body capacity and the level of manufacturers’ preparedness with high level of public health protection.

• 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

Given the urgent nature of this proposal, 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, allowing for additional time to transition to the MDR’s requirements to avoid shortages. The need to act quickly to ensure certainty ahead of the Regulation’s current end of transition period did not allow for a broad public consultation. The Commission therefore collected the necessary input from Member States and stakeholders through targeted exchanges.

The initiative aims to assure that patients throughout Europe have access to safe medical devices. As more and more certificates will expire before the May 2024 deadline, the Commission has committed to adopt a proposal in January 2023. This is backed up by urgent calls from the European Parliament, Member States and stakeholders, namely healthcare professionals, patients, academia, scientific bodies, industry and notified bodies. Input from Member States and stakeholders has been sought through targeted interaction, mainly in the framework of the Medical Device Coordination Group (MDCG) with meetings on 24-25 August, 24-25 October and 17 November 2022, dedicated to capacity and preparedness issues. Following a debate in the European Parliament on 24 November 2022 (oral question www.europarl.europa.eu/doceo/document">O-43/2022 ), the European Parliament’s Committee on Environment, Public Health and Food Safety requested an urgent targeted amendment in a letter of 5 December 2022. An exchange of views with Member States took place on 9 December 2022 during the EPSCO Health Council ¹⁸ ; almost all Member States took the floor and supported the urgent adoption of a targeted amendment of the MDR and IVDR as suggested by the Commission.

The Commission will continue to closely monitor the developments and the impact of the proposed amendments on the market. It will also consult with the MDCG and stakeholders about the need for complementary actions.

4. BUDGETARY IMPLICATIONS

The proposed action has no budgetary implications.

5. OTHER ELEMENTS

• Detailed explanation of the specific provisions of the proposal

Article 1 contains the proposed amendments to Article 120(2), (3) and i and to Articles 122 and 123 of the MDR. Article 2 contains the amendments to Article 110 i and to Article 112 of the IVDR.

• Article 1(1), point (a), of the proposal – extension of the validity of certificates

This provision amends Article 120(2) MDR. It extends the validity of certificates issued under Council Directives 90/385/EEC or 93/42/EEC that were valid on the day of the MDR’s date of application (26 May 2021) 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 transition period laid down in the proposed Article 120(3a) to (3c) of the MDR. As regards certificates that have already expired when the proposed amendment comes into force, the extension would 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 59 of the MDR or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.

• Article 1(1), point (b), of the proposal – extension of the transition period

This provision amends Article 120(3) MDR. Due to the length of the provision, paragraph 3 is replaced by paragraphs 3a to 3g. The transition period is extended from 26 May 2024 until 31 December 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the MDR provides exemptions, given that these devices are considered to be based on well established technologies) and until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).

In the same way as the current Article 120(3) MDR, the extended transition period applies only to ‘legacy devices’, i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.

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

●the devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR;

●the devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR;

●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 94 and 95 of the MDR. No systematic check of the device’s safety is required, as devices covered by a certificate issued under the Directives will be under ‘appropriate surveillance’ by the body that issued the certificate or a notified body designated under the MDR. 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 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR 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. However, by submitting an application for conformity assessment to a notified body (see next condition), the manufacturer implicitly confirms that its QMS is in compliance with the MDR;

●no later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application in accordance with Annex VII, Section 4.3, of the MDR for conformity assessment in respect of a ‘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 MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3, of this Regulation. This condition aims to ensure that only devices that the manufacturer intends to transition to the MDR 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 26 May 2024. 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 the AIMDD or MDD 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 MDR 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 MDR needs to be signed, that notified body would by default become responsible for the appropriate surveillance.

The amendment introduces a transition period until 26 May 2026 also for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR. While manufacturers of class III implantable custom-made devices are required to comply with all applicable MDR requirements since 26 May 2021, they will now be given more time to obtain certification of their quality management system by a notified body. Also in this case, the transition period only applies if the manufacturer has lodged an application before 26 May 2024 resulting in the signing of a contract with the notified body before 26 September 2024.

• Article 1(1), point (c), of the proposal – deletion of the ‘sell-off’ deadline in the MDR

This provision deletes the current ‘sell-off’ date (27 May 2025) in Article 120 i MDR. Consequently, devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.

• Article 1(2) and (3) of the proposal – adaptation of Articles 122 and 123 MDR

This provision adapts Articles 122 and 123 MDR to reflect the extended transition period and the deletion of the ‘sell-off’ deadline.

• Article 2(1) of the proposal – deletion of the ‘sell-off’ deadlines in the IVDR

This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in Article 110 i IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction.

• Article 2(2) of the proposal – adaptation of Article 112 IVDR

This provision adapts Article 112 IVDR to reflect the deletion of the ‘sell-off’ deadlines.