Newsletter | January 2022 For more information and regular updates please consult our website HERE. As intensive efforts continue for the application of the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), we strive to keep you up to date on all relevant news and events. In this issue of our newsletter we update you on the progressive roll-out of the IVDR, and on the application of the MDR as regards Eudamed and electronic instructions for medical device use, among other news. In this issue • Progressive roll-out of the IVDR
• Notice to manufacturers outside EU / EAA of in vitro diagnostic medical devices to detect and/or quantify markers of SARS-CoV-2 infection
• Eudamed Implementing Act
• Rules on MDR application as regards electronic instructions for use of medical devices
• MDCG 2021-27 Q&A on Articles 13 & 14 of MDR & IVDR related to importers and distributors
• Implementing decisions on harmonised standards for MDR and IVDR
• Proposal for extending the mandate of the European Medicines Agency
• Adoption of the Regulation on health technology assessment Progressive roll-out of the IVDR
The Commission proposal amending the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 in order to ensure a smooth transfer from the current IVDD to IVDR has been agreed by the European Parliament and the Council within an exceptionally swift process and without any amendments to the Commission text. The IVDR will still apply as from 26 May 2022 for new IVDs as well as Class A sterile devices and be progressively rolled out according to risk class. The amended Regulation is expected to be formally signed, published on the OJ and enter into application before the end of January 2022.
Welcoming the agreement by the co-legislators to the amendment, Commissioner for Health and Food Safety Stella Kyriakides said: “In the midst of an unprecedented public health crisis, we cannot risk shortages of essential medical devices. Health systems and routine health services have been tested like never before. The pandemic has at the same time highlighted the vital need for accurate diagnostics and a resilient regulatory framework for in vitro medical devices. The amendment of the In Vitro Diagnostic Medical Devices Regulation will ensure that crucial medical devices, such as COVID or HIV tests, continue to be available and safe. Member States, manufacturers and notified bodies must now use the additional time to build up the necessary capacities, and manufacturers must prepare to transition to the new requirements. There is no time to rest.”
For more, see here.
Notice to manufacturers outside EU / EAA of in vitro diagnostic medical devices to detect and/or quantify markers of SARS-CoV-2 infection
The Medical Device Coordination Group (MDCG) has endorsed a notice addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection that are based in countries outside the EU or the EEA and that place or intend to place the abovementioned devices on the EU market.
The notice is intended to highlight a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. These issues can also be relevant for SARS-CoV-2 devices which are transitioning to Regulation (EU) 2017/746.
For more, see here.
Eudamed Implementing Act
In November 2021, the European Commission published Implementing Regulation (EU) 2021/2078, laying down rules for the application of Regulation (EU) 2017/745 as regards the European Database on Medical Devices (Eudamed).
Regulation 2021/2078 establishes the provisions for accessing Eudamed, the registration process, the nomenclature to be used in Eudamed, technical and administrative support, ownership and processing of personal data, functioning rules, malfunctions, websites for testing and training purposes, IT security, and fraudulent user activity within Eudamed
For the full text of the Commission Implementing Regulation see here.
Rules on MDR application as regards electronic instructions for use of medical devices
The European Commission has published Implementing Regulation (EU) 2021/2226, laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use (eIFUs) of medical devices.
This Implementing Regulation establishes the conditions under which information in the instructions for use, as defined by Article 2(14) of the MDR and detailed in Annex I, Chapter III, point 23.4 to the MDR, may be provided by manufacturers in electronic form. It also establishes certain requirements concerning contents of websites and instructions for use that are provided in electronic form in addition to instructions for use in paper form.
For the full text of the Commission Implementing Regulation see here.
MDCG 2021-27 Q&A on Articles 13 & 14 of MDR & IVDR related to importers and distributors
The Medical Device Coordination Group (MDCG) has endorsed a series of questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices. The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations.
For the full text MDCG 2021-27, click here.
Implementing decisions on harmonised standards for MDR and IVDR
The European Commission has published two Implementing Decisions on harmonised standards in support of the Medical Devices Regulation (EU) 2017/745 and of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. These publications amend and enlarge the first lists of references published in July 2021, now providing 14 harmonised standards for the MDR and 9 harmonised standards for the IVDR overall.
The voluntary use of harmonised standards cited in the Official Journal of the European Union confers a presumption of conformity with the requirements of the Regulations the standards aim to cover.
For more information, see the “Harmonised European standards” section here.
Proposal for extending the mandate of the European Medicines Agency
On 11 November 2020, the Commission published a legal proposal to expand the European Medicines Agency (EMA)'s mandate to act in preparation for and during public-health emergencies.
The Commission has proposed to give the EMA the legal mandate to, ex multis, monitor and mitigate shortages of medical devices during public-health emergencies and to transfer to EMA the tasks currently assigned to the Commission of managing 'EU Expert Panels' for clinical evaluation of certain high-risk medical devices and in-vitro diagnostics that are being set up according to the MDR.
A political agreement between the Council and the European Parliament was reached on 28 October 2021 and the formal adoption and entry into force is expected at the end of January/beginning of February 2022, with the actual transfer of the management of the Expert Panels to take place as of March 2022 and shortages monitoring of medical devices 12 months after entry into force.
This proposal is the first legislative proposal of the Commission’s European Health Union package from November 2020 to be concluded.
For more information, see here.
Adoption of the Regulation on health technology assessment
The Regulation on health technology assessment (HTA) entered into force in January 2022 and will apply as of January 2025. The Regulation on HTA contributes to improving the availability of innovative technologies in the area of health, such as medicines and certain medical devices, for EU patients, it ensures efficient use of resources and strengthens the quality of HTA across the Union.
The Regulation provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities and a stakeholder network, and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. It will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation.
For more information, see here.
Stay tuned for future updates!
To stay up to date on all information related to medical devices and in vitro medical devices within the context of the new Regulations make sure to visit the Medical Devices section on the Commission website regularly.
For more information and regular updates
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