R&I

Interested in finding out how your medical technology company can participate in the Innovative Health Initiative (IHI)?

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R&I

Start-ups & Small and Medium-sized Enterprises (SMEs) can now apply as Partners in Research

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MDR

Making the EU Medical Devices Regulation more workable

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IVDR

Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation

Read the latest edition!

MedTech Europe Code of Ethical Business Practice

Check out the revised version

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Latest updates

Resource library Health Data

Joint Statement: health organisations define EHDS’ opt out required for life saving research

On 6 June, MedTech Europe joined together with 31 other health stakeholders to share views on specific recommendations for a potential opt-out mechanism in the future EHDS. These organisations and initiatives have joined forces because they all share the view that health data are precious and renewable resources that can power decision-making for clinical care, deliver life-saving innovations, and strengthen health systems in the 21st century. Discussions in the EU policy-making process now include proposals for an opt-out mechanism for citizens to withdraw their data from secondary use purposes (that is, from research, regulatory purposes and evidence based policy making). The original European Commission proposal did not include this mechanism. The group of stakeholders support the approach taken in the Commission’s original legislative proposal from May 2022 as it strikes a sensible balance between protection of personal data while enabling the use of data for research and innovation to create tangible benefits for patients and citizens. The stakeholders raise concerns about the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary use research purposes if an opt-out or opt-in mechanism is approved, and call for an impact assessment that will inform implementation of this policy option. If the proposals for opt-out are approved in the final EHDS legislation, the group make six recommendations. They believe the opt-out mechanism should: be applicable across all Health Data Access Bodies in EU Member States, limiting the scope of national derogation and ensuring that the technical specifications are aligned. consider the impact on health and care professionals and for other data holders. be capable of implementation across the EU, without limiting lawful and ethical data sharing for secondary purposes. be routinely monitored as part of a regularly updated [email protected] data governance framework. have a limited, but well-defined, consistent and transparent scope. have necessary investment, infrastructure and budget to ensure sufficient transparency so that citizens are well informed of the opt-out. Finally, the current debate on enabling secondary use of health data in Europe highlights the need to achieve stakeholder alignment where possible on the implementation journey ahead for the EHDS. It also speaks to the need for implementation decisions to be highly informed by those with experience and responsibilities for on-the-ground implementation. This reiterates a need for strong, balanced and inclusive stakeholder representation within the governance model of the EHDS such as its Board of Directors. Read the full statement below.

Posted on 06.06.2023

A successfully thought-provoking MedTech Forum 2023

Posted on 05.06.2023

MedTech Europe’s vision for cybersecurity in the medical technology ecosystem – position paper

The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring the safety and security of MDs and IVDs, but also on the protection of patients’ and users’ confidential data. As such, medical device manufacturers invest substantial resources in guaranteeing state of the art cybersecurity for all their products and services, ensuring the resilience of the digital health ecosystem. In this position paper, MedTech Europe outlines three key areas of discussion for regulators, medical device manufacturers, healthcare systems and society-at-large. Firstly, that the security of medical technologies continues to be regulated under sectoral legislation. The Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation (‘MDR’ and ‘IVDR’) lay out essential requirements for digital medical technologies and services, including Medical Device Software (MDSW) placed on the EU market. In addition, MDCG 2019-16 rev.1 guidance on cybersecurity, provides medical technology manufacturers with the necessary guidance on fulfilling the relevant General Safety and Performance Requirements of MDR and IVDR respectively, with regards to cybersecurity. It also provides guidance on how to comply with both the Network and Information Security Directive (‘NIS1’), and the General Data Protection Regulation (‘GDPR’), both of which apply to medical technology manufacturers. Secondly, the paper underlines MedTech Europe’s commitment against ransomware, and other malicious interference with healthcare delivery in Europe. MedTech Europe welcomes legislative interventions aimed at reinforcing existing cybersecurity responsibilities and curbing tactics employed by potential cyber-attackers and cyber-criminals. The ongoing digital transformation of society and the lagging digitalisation of healthcare institutions and healthcare delivery continue to lead to healthcare being prime target for malign actors. MedTech Europe welcomed the revision of the Network and Information Security Directive (known as ‘NIS2’), as a means of reinforcing the digital resilience of states and businesses, while ensuring that they increase their investments in cybersecurity. While we welcome such legislative intervention, we believe that it should be combined with tangible investments in organisations’ security postures, resilience of digital tools and processes, and the investment in people and the skills necessary to deliver on such legislation. Finally, the paper highlights MedTech Europe’s support for measures aimed at improving the level of overall digital literacy, and particularly, cybersecurity skills. The evolving cybersecurity threat landscape coupled with a significant European cybersecurity skills shortage is an untenable situation, and must be addressed. MedTech Europe supports a public-private partnership approach to confront these issues. We also applaud the European Commission’s efforts to improve the situation, particularly through the European Skills Agenda Digital Education Action Plan, as well as the recently published communication for a Cybersecurity Skills Academy. Please find the full position paper below.

Posted on 23.05.2023

My family’s encounter with antimicrobial resistance

Pernilla Rönnholm, from Gothenburg, Sweden, shared the story of how antimicrobial resistance affected her family and her life.

Can IVD market sustain stellar growth?

Europe’s in vitro diagnostics (IVD) market has expanded sharply since 2020, with demand for SARS-CoV-2 tests driving double-digit growth for the past two years.

About us

MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure.

We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 500,000 products, services and solutions currently made available by the medical technology industry. These range from bandages, blood tests and hearing aids to cancer screening tests, pacemakers and glucose monitors.

Our sector employs more than 730,000 people. There are more than 32,000 medical technology companies in Europe, of which 95% are SMEs.