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Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)

Type Regulation
Publication 2022-01-31
Last updated 2025-01-01
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 38
Reform history JSON API
  • (a) submit the set of information referred to in Article 25(2), point (d), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);
  • (b) indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 26(3);
  • (c) indicate any failure to provide requested information and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 26(2).

Member States shall comply with the Agency’s request by the deadline set by the Agency.

2.

For the purposes of paragraph 1, Member States shall gather information from manufacturers of medical devices and their authorised representatives, healthcare providers, importers and distributors, as applicable, and notified bodies on medical devices included on the public health emergency critical devices list.

3.

Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 21(5), second subparagraph.

4.

Following the reporting on the results of the monitoring referred to in Article 23 and any recommendations on preventive or mitigating measures provided in accordance with Article 24, Member States shall:

  • (a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list while ensuring a high level of patient and product safety;
  • (b) take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);
  • (c) inform the MDSSG of any measures taken and report on the results of the actions referred to in point (b), including providing information on the resolution of the actual or potential shortage of medical devices concerned.

For the purposes of the first subparagraph, points (b) and (c), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MDSSG.

The recommendations, guidelines and actions referred to in the first subparagraph, point (b), of this paragraph, and a summary report of the lessons learned shall be made publicly available via the web portal referred to in Article 29.

Article 28

Role of the Commission regarding the monitoring and mitigation of shortages of medical devices

The Commission shall take into account the information from and recommendations of the MDSSG and shall:

  • (a) take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while respecting the conditions set out in those Articles and seeking to ensure both patient and product safety;
  • (b) consider the need for guidelines and recommendations to be addressed to Member States, manufacturers of medical devices, notified bodies, and other entities, where relevant;
  • (c) request the MDSSG to provide recommendations or coordinate measures provided for in Article 24(3), (4) and (5);
  • (d) consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law;
  • (e) liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medical devices included on the public health emergency critical devices list or their component parts, where those devices or parts of such devices are imported into the Union, and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MDSSG, where relevant.

Article 29

Communication regarding the MDSSG

1.

The Agency shall provide information to the public and relevant interest groups with regard to the work of the MDSSG in a timely manner and shall respond to disinformation targeting the work of the MDSSG, as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.

2.

Proceedings of the MDSSG shall be transparent.

The summaries of the agenda and of the minutes of the meetings of the MDSSG, as well as its rules of procedure referred to in Article 21(4) and recommendations referred to in Article 24(3) and (4), shall be documented and made publicly available on the dedicated webpage on the Agency web portal.

Where the rules of procedure referred to in Article 21(4) allow members of the MDSSG to have divergent opinions recorded, the MDSSG shall make such divergent opinions, and the grounds on which they are based, available to national competent authorities at their request.

Article 30

Support for the expert panels on medical devices

From 1 March 2022, on behalf of the Commission, the Agency shall provide the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) and shall provide the support necessary to ensure that those expert panels can efficiently perform the tasks set out in Article 106(9) and (10) of that Regulation.

The Agency shall:

  • (a) provide administrative and technical support to the expert panels for the provision of scientific opinions, views and advice;
  • (b) facilitate and manage remote and physical meetings of the expert panels;
  • (c) ensure that the work of the expert panels is carried out in an independent manner in accordance with Article 106(3), second subparagraph, and Article 107 of Regulation (EU) 2017/745 and with the systems and procedures established by the Commission pursuant to that Regulation to actively manage and prevent potential conflicts of interest in accordance with Article 106(3), third subparagraph, of that Regulation;
  • (d) maintain and regularly update a webpage for the expert panels and make all necessary information not already publicly available in Eudamed publicly available on that webpage in order to ensure the transparency of the activities of the expert panels, including providing the justifications of notified bodies where those bodies did not follow the advice of the expert panels provided pursuant to Article 106(9) of Regulation (EU) 2017/745;
  • (e) publish the scientific opinions, views and advice of the expert panels while ensuring confidentiality in accordance with Article 106(12), second subparagraph, and Article 109 of Regulation (EU) 2017/745;
  • (f) levy fees in accordance with Article 106(14) of Regulation (EU) 2017/745 and ensure that remuneration and expenses are provided to experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745;
  • (g) monitor compliance with the expert panels’ common rules of procedure and available guidelines and methodologies relevant to the functioning of the expert panels;
  • (h) provide annual reports to the Commission and the MDCG on the work of the expert panels, including information on the number of opinions delivered and the views and advice provided by the expert panels.

CHAPTER V FINAL PROVISIONS

Article 31

Cooperation between the MSSG, the MDSSG, the ETF and the expert panels

1.

The Agency shall ensure that the MSSG and the MDSSG cooperate in relation to measures to address public health emergencies and major events.

2.

Members of the MSSG and MDSSG, and members of the working parties referred to in Article 3(6) and in Article 25(2), point (a), respectively, may attend one another’s meetings and working parties and, where appropriate, cooperate on monitoring exercises, reporting and the preparation of opinions.

3.

With the agreement of the respective chairs or co-chairs, joint meetings of the MSSG and the MDSSG may be held.

4.

Where relevant, the Agency shall ensure that the ETF and the expert panels cooperate in relation to preparedness and management of public health emergencies.

Article 32

Transparency and conflicts of interest

1.

The MSSG and the MDSSG shall carry out their activities in an independent, impartial and transparent manner.

2.

The members of the MSSG and of the MDSSG and, where relevant, observers, shall not have any financial or other interests in the medicinal products industry or medical devices industry which could affect their independence or impartiality.

3.

The members of the MSSG and the MDSSG and, where relevant, observers, shall make a declaration of their financial and other interests and shall update those declarations of interest annually and whenever necessary.

The declarations referred to in the first subparagraph shall be made publicly available on the Agency’s web portal.

4.

The members of the MSSG and the MDSSG and, where relevant, observers, shall disclose any other facts of which they become aware that might reasonably be expected in good faith to involve or give rise to a conflict of interest.

5.

Before each meeting, the members of the MSSG and the MDSSG and, where relevant, observers who participate in meetings of the MSSG and the MDSSG shall declare any interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda.

6.

Where the Agency decides that an interest declared in accordance with paragraph 5 constitutes a conflict of interest, the member or observer concerned shall not take part in any discussions or decision making, or obtain any information, concerning the item of concern on the agenda.

7.

The declarations and the decisions of the Agency referred to in paragraphs 5 and 6, respectively, shall be recorded in the summary minutes of the meeting.

8.

The members of the MSSG and the MDSSG and, where relevant, observers, shall be subject to a requirement of professional secrecy, even after their duties have ceased.

9.

Members of the ETF shall update the annual declaration of their financial or other interests provided for in Article 63 of Regulation (EC) No 726/2004 whenever a relevant change to their declaration occurs.

Article 33

Protection against cyber attacks

The Agency shall equip itself with a high level of security controls and processes against cyber attacks, cyber espionage and other data breaches to ensure the protection of health data and the normal functioning of the Agency at all times, especially during public health emergencies or major events at Union level.

For the purposes of the first paragraph, the Agency shall actively identify and implement cybersecurity best practices adopted within Union institutions, bodies, offices and agencies for preventing, detecting, mitigating, and responding to cyber attacks.

Article 34

Confidentiality

1.

Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council ([^E0002]) and Directive (EU) 2019/1937 of the European Parliament and of the Council ([^E0003]), and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council ([^E0004]), including intellectual property rights.

2.

Without prejudice to paragraph 1, all parties involved in the application of this Regulation shall ensure that no commercially confidential information is shared in a way which has the potential to enable undertakings to restrict or distort competition within the meaning of Article 101 TFEU.

3.

Without prejudice to paragraph 1, information exchanged on a confidential basis between national competent authorities and between national competent authorities and the Commission and the Agency shall not be disclosed without the prior agreement of the authority from which that information originates.

4.

Paragraphs 1, 2, and 3 do not affect the rights and obligations of the Commission, the Agency, Member States or other actors identified in this Regulation with regard to the exchange of information and the dissemination of warnings, nor do they affect the obligations of the persons concerned to provide information under criminal law.

5.

The Commission, the Agency, and Member States may exchange commercially confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Article 35

Personal data protection

1.

Transfers of personal data under this Regulation shall be subject to Regulations (EU) 2016/679 and (EU) 2018/1725, as applicable.

2.

As regards transfers of personal data to a third country, in the absence of an adequacy decision or appropriate safeguards as referred to in Article 46 of Regulation (EU) 2016/679 and Article 48 of Regulation (EU) 2018/1725 respectively, the Commission, the Agency, and Member States may carry out certain transfers of personal data to regulatory authorities of third countries with which they have put in place confidentiality arrangements where those transfers are necessary for important reasons of public interest, such as the protection of public health. Such transfers shall be made in conformity with the conditions laid down in Article 49 of Regulation (EU) 2016/679 and Article 50 of Regulation (EU) 2018/1725.

Article 36

Reporting and review

1.

By 31 December 2026, and every fourth year thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. In particular, that report shall review:

  • (a) the crisis preparedness and management framework for medicinal products and medical devices, including the outcomes of periodic stress tests;
  • (b) instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies;
  • (c) the remit and functioning of the ESMP.
2.

Notwithstanding paragraph 1, following a public health emergency or a major event, the Commission shall present, in a timely manner, a report to the European Parliament and the Council on the instances referred to in paragraph 1, point (b).

3.

Based on the report referred to in paragraph 1, the Commission shall, where appropriate, present a legislative proposal in order to amend this Regulation. In particular, the Commission shall consider the need for:

  • (a) extending the scope of this Regulation to veterinary medicinal products and to personal protective equipment for medical use;
  • (b) amending Article 2;
  • (c) introducing measures to strengthen at Union or national level compliance with the obligations established in Articles 10 and 26; and
  • (d) expanding the remit of the ESMP, the need for further facilitating the ESMP interoperability with national and Union IT systems, the need for national shortage monitoring platforms, and the need for meeting any additional requirements to address structural shortages of medicinal products that may be introduced in the context of a revision of Directive 2001/83/EC and Regulation (EC) No 726/2004.

Article 37

Union financing

1.

The Union shall provide the financing of the Agency’s activities in support of the work of the MSSG and the MDSSG, the ETF, the working parties referred to in Article 3(6) and in Article 25(1), point (c), and the expert panels, that involve its cooperation with the Commission and the ECDC.

The Union’s financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council ([^E0005]).

2.

The Agency shall remunerate the assessment activities of the rapporteurs in relation to the ETF under this Regulation, in addition to reimbursing the expenses incurred by Member States’ representatives and experts in relation to the meetings of the MSSG, the MDSSG, the ETF and the working parties referred to in Article 3(6) and in Article 21(5), in accordance with financial arrangements established by the Management Board of the Agency. Such remuneration shall be paid to the relevant national competent authorities.

3.

The Union contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the tasks of the Agency provided for under this Regulation, and shall cover the full amount of remuneration paid to national competent authorities for medicinal products where fee exemptions apply in accordance with Council Regulation (EC) No 297/95 ([^E0006]).

Article 38

Entry into Force and date of application

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 March 2022.

However, with the exception of Article 30, Chapter IV shall apply from 2 February 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

[^E0001]: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

[^E0002]: Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

[^E0003]: Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).

[^E0004]: Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

[^E0005]: Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

[^E0006]: Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1).

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