e-News : Health and Food Safety Directorate General

Implementing regulation establishing the rules forjoint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation has been published.

Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices

Today, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices andin vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation.    

The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering:

·the submission of requests from health technology developers;

·the selection and consultation of stakeholder organisations and patients, clinical and other relevant experts;

·cooperation with the European Medicines Agency (EMA) where a medical device developer requests a joint scientific consultation to be undertaken, in parallel with an expert panel consultation.

Joint scientific consultations enable health technology developers to exchange information with HTA bodies on their development plans for a medical device or anin vitro diagnostic medical device, in scope of the HTA Regulation. They allow developers to obtain guidance on the development of clinical evidence likely to be required for subsequent joint clinical assessments of such devices.           

The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This is the fifth implementing act adopted under the HTA Regulation. The HTA Regulation became applicable on 12 January 2025

MedTech Europe本周发布信息

Competitiveness Compass: Speed and unity are critical for delivery

Brussels, 29 January 2025– MedTech Europe welcomes the publication of the European Commission’s Competitiveness Compass and its objective to “safeguard the EU’s future as an economic powerhouse.” We fully support the Commission’s ambitions and now call on it to deliver tangible actions through its upcoming flagship initiatives.

The medical technology sector is a vital pillar of Europe’s life sciences ecosystem, and we appreciate the recognitionin the Competitiveness Compass that investing in life sciences holds significant potential for boosting competitiveness across multiple sectors. The message is clear: no health, no wealth.

Oliver Bisazza, CEO of MedTech Europe commented: “We are encouraged by the report’s focus on life sciences as a critical area to Europe’s sustainable competitiveness and by its wealth of related flagship initiatives. Turning this ambitious plan into tangible outcomes is now the challenge: speed and unity of all actors, including the Commission, Member States, investors, industry and other stakeholders will now be of the essence.”

We also commend the Commission’s acknowledgment of the need for regulatory simplification in the medical technology sector and insist it should include both the Medical Devices and theIn Vitro Diagnostic Regulations. Both immediate action and long-term reform are essential to closing the innovation launch gap, enabling European patients and healthcare systems to access groundbreaking technologies more swiftly.

Furthermore, we support the commitment to maintaining the EU’s climate goals. Climate, health, and competitiveness are intrinsically linked. MedTech Europe has publishedrecommendations on how to effectively implement the Green Deal within healthcare and stands ready to collaborate on this critical agenda.

As the EU charts its course towards sustainable competitiveness and prosperity, MedTech Europe remains available to contribute constructively to shaping these policies for the benefit of people in Europe, and its healthcare systems.

MedTech Europe本周发布信息

Industry Coalition Calls for Withdrawal of AI Liability Directive

MedTech Europe, together with other 11 associations, have issued on 29 January 2025 a joint statement calling on EU policymakers to withdraw the AI Liability Directive (AILD) proposal. This directive risks adding legal complexity, harming EU competitiveness by increasing burdens and deterring investment in AI innovation.

The recently adopted PLD should be implemented and tested before considering new liability frameworks, while the impact of the EU AI Act and GDPR still remains unassessed. The AILD also risks severely disrupting current liability practices, which are crucial for managing responsibilities and fostering innovation.

This approach is fundamentally misaligned with the Commission’s Sustainable Prosperity Deal, as backed up by the Draghi Report which highlights the need for a clear and streamlined legal framework for AI in Europe.

The withdrawal of the AILD would reaffirm the EU’s commitment to follow through on the Draghi Report’s recommendations – and help shape a clearer legal framework for AI, truly conducive to innovation and competitiveness.

BfArm本周发布信息

Field Corrective Actions

SWISS Medic本周发布信息

New Swiss Good Practice in the maintenance of medical devices

The legal requirements for the maintenance of medical devices are set out in Art. 71 of the Medical Devices Ordinance (MedDO, SR 812.213) and Art. 64 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219).

The «Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten» (GPI) is the guideline that describes the requirements according to Art. 71 para. 4 MedDO and Art. 64 para. 4 IvDO. Its application is mandatory for all hospitals and any deviations must be assessed accordingly, remedied or justified and documented if necessary. The implementation of the GPI in hospitals is reviewed by Swissmedic as part of administrative proceedings, including inspections.

GPI was prepared by Swissmedic in collaboration with the professional associations «Infrastruktur Hospital Schweiz» (IHS) and «Interessengemeinschaft für Wiederaufbereitung im Gesundheitswesen» (IG WiG).

Based on the input from the consultation in mid-2024, the GPI was restructured and certain topics were expanded for a better understanding. No significant changes were made to the content. Suggestions for improvement of a next version of the GPI are welcome.

Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten (German, French)(PDF, 717 kB, 31.01.2025)

The following checklist is based on GPI version 2 from 2025 and Swissmedic uses it when inspecting hospitals with regard to the maintenance of medical devices. It can be used by healthcare facilities to perform gap analyses with regard to GPI requirements and for internal audits, for example.

The following document (available in German, French and Italian) provides details of the requirements for the maintenance of sterilization containers (in accordance with standard SN EN 868-8):

In 2017, the Federal Office of Public Health and Swissmedic issued guidelines for operating and monitoring heater-cooler devices/units in operating theatres on the basis of recommendations issued by the Swiss Mycobacterium chimaera expert task force.

Richtlinien zum Betrieb und zur Überwachung von Heater-Cooler Devices (HCDs) im Operationssaal (PDF, 344 kB, 27.01.2017)

New medical devices regulations came into force on 26 May 2021. An information meeting was held (in French and German) on 2 September 2021 to explain the impact of the new regulations on the different players in the Swiss medical devices sector.

Information on the new medical devices regulations (French and German only):

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