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EU rules on medical devices and in vitro diagnostics - targeted evaluation

Public health

Regulations (EU) 2017/745 and (EU) 2017/746 on medical devices and on in vitro diagnostics aim at ensuring availability of safe, performant and innovative devices, with a view to fostering the competitiveness of the sector, while protecting patient safety and public health. In a focussed and targeted evaluation, the Commission will take stock and assess whether the rules are effective, efficient and proportionate, meet current and emerging needs, align with other actions and have EU added value.

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Public consultation

ID: 14155

Lobbying Activity

69 responses

Consultation response

Bureau Européen des Unions de Consommateurs, 21 Mar 2025

Consumers use medical devices in their daily lives. Ensuring that they are safe, perform well, and improve peoples health and well-being, is paramount. In the aftermath of scandals that eroded trust in the regulatory system (ref. 1,2) in 2017 the EU tightened the rules for the approval of devices.…

Consultation response

American Chamber of Commerce to the European Union, 21 Mar 2025

Whilst the objectives of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) to enhance patient safety are laudable, their regulatory burden, lengthy approval processes, increased uncertainty and elevated clinical evidence requirements have negatively impacted…

Consultation response

European Federation of Pharmaceutical Industries and Associations, 21 Mar 2025

EFPIA welcomes the European Commissions initiative to evaluate the IVDR and MDR. In the context of a possible revision of these legislations, EFPIA strongly supports targeted amendments to establish a proportionate, risk-based, and EU-coordinated regulatory framework. Both Regulations, while aiming…

Bayer seeks regulatory relief for medical devices in drug trials

Bayer AG, 20 Mar 2025

Bayer requests exemptions from distributor verification requirements for medical devices co-packaged with medicines, clarification that repackaging such devices doesn't trigger manufacturer obligations, and allowance for in-house diagnostic testing outside the EU for clinical trials. They seek to remove notification requirements when using leftover samples in performance studies already approved through CTIS.
This would reduce handling costs and delays in the supply chain for combination products.
Patient safety oversight loses additional verification checkpoints in the distribution chain.

Consultation response

Confederation of Danish Industry, 21 Mar 2025

Please find attached the feedback on the EU rules on medicial devices and in vitro diagnostics from Danish Industry

Medicines for Europe calls for MDR overhaul to reduce regulatory burden

MEDICINES FOR EUROPE, 21 Mar 2025

The organization requests clearer classification rules for drug delivery devices, defined notified body timelines, and streamlined evaluation processes to avoid duplication. They propose device master files similar to those for pharmaceutical ingredients and a coordination group for devices used with medicines.
This would reduce their compliance costs and development time by eliminating duplicate assessments.

Consultation response

Deutsche Industrie- und Handelskammer, 21 Mar 2025

Vielen Dank für die Möglichkeit zu den EU-Verordnungen 2017/745 über Medizinprodukte (MDR) und 2017/746 über In-Vitro-Diagnostika (IVDR) Stellung zu nehmen. Unsere Vorschläge finden Sie in der beigefügten Stellungnahme.

Consultation response

MedTech Europe, 20 Mar 2025

MedTech Europe welcomes the European Commissions targeted evaluation of EU rules on medical devices and in vitro diagnostic medical devices. Ensuring delivery of healthcare to patients and competitiveness of the medical technologies industry which delivers the medical devices and diagnostics to our…

Consultation response

Ibec, 21 Mar 2025

Irish Medtech, Ibecs trade association for the medtech sector in Ireland, welcomes the opportunity to provide the views of Irish medtech companies in response to the public consultation: targeted evaluation of the EU rules on medical devices and in vitro diagnostics. Irish Medtech welcomes the…

Consultation response

European Disability Forum, 21 Mar 2025

The right to the highest attainable possible standard of health without discrimination based on disability is a fundamental principle enshrined in international human rights treaties and the EU Charter of Fundamental Rights. Additionally, 22 Member States either prohibit disability discrimination…

Consultation response

EuropaBio, 20 Mar 2025

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of the Regulation on Medical Devices (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR). EuropaBio emphasises the need to improve the interplay between the…

Consultation response

European Patients' Forum (EPF), 20 Mar 2025

The European Patients Forum (EPF) welcomes a thorough review of the Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Commission to assess gaps and benefits of the legislation. As a first step, EPF believes increased coordination, guidance,…

Consultation response

EUROPEAN ORGANISATION FOR RARE DISEASES, 21 Mar 2025

EURORDIS-Rare Diseases EURORDIS Rare Diseases Europe is a non-profit alliance of over 1100 rare disease patient organisations from 75 countries that work together to improve the lives of over 30 million people living with a rare disease in Europe. By connecting patients, families and patient…

Consultation response

Association of the European Self-Care Industry, 20 Mar 2025

The Association of the European Self-Care Industry (AESGP) representing manufacturers of self-care medical devices (i.e. devices that are generally available without medical prescription and are self-administered) welcomes the European Commissions targeted evaluation of the EU rules on medical…

Consultation response

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 20 Mar 2025

Eight years into the EU Regulations for medical devices and in vitro diagnostics (MDR/IVDR), structural challenges regarding the governance system have become apparent. These challenges relate to a lack of clear accountability, transparency, and involvement of stakeholders. Moreover, the governance…

Consultation response

Siemens Healthineers AG, 21 Mar 2025

Please see the attachement.

Consultation response

Deutsche Sozialversicherung Europavertretung, 17 Mar 2025

The MDR is an important step towards improving patient safety and the quality of treatment with medical devices. This premise must remain in place during the planned evaluation and a possible adaptation of the MDR. From the DSV's point of view, it is also not necessary to renegotiate the entire…

Consultation response

TIC Council, 21 Mar 2025

The TIC Council, the international trade association representing independent testing, inspection and certification bodies, and specifically the Notified Bodies under the MDR and all bodies providing confirmity assessment services, looks forward to engaging with the European Commission and all…

Consultation response

AGORIA, 14 Mar 2025

As the opportunity is given, this document provides some feedback on the MDR and outlines potential solutions. While some European organizations with whom we are in contact, primarily represent large corporations, this feedback focuses therefore on the perspectives of startups, small and medium…

Consultation response

Association of European Cancer Leagues, 21 Mar 2025

The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was intended to strengthen patient safety and modernise the regulatory framework in Europe. However, several years into implementation, significant challenges have emerged. Particularly, Europes…

Consultation response

European Heart Network, 20 Mar 2025

The European Heart Network (EHN) advocates for improved access to life-saving medical devices for cardiovascular patients in Europe, particularly for paediatric and rare disease care. While medical devices play a crucial role in patient outcomes, the European Unions Medical Devices Regulation (MDR)…

Consultation response

European Society for Medical Oncology (ESMO), 18 Mar 2025

The European Society for Medical Oncology (ESMO) - a professional society representing over 40,000 members from 179 countries and territories - welcomed the EUs revision of its laws governing medical devices and in vitro diagnostics as, given the developments of the sector over the last 20 years,…

Consultation response

TÜV-Verband e. V., 21 Mar 2025

The TÜV Association is of the opinion that the MDR and IVDR have only partially achieved their goal of establish[ing] a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health while supporting innovation (cf. Recital…

Consultation response

Amgen Inc, 21 Mar 2025

Amgen recommends targeted amendments to the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 to establish a proportionate, risk-based, and EU-coordinated regulatory framework that streamlines drug-IVD clinical trial processes and timelines, reduces administrative burdens, and…

Consultation response

Bundesärztekammer, 21 Mar 2025

(for the English version, please see attached pdf file) Die Bundesärztekammer dankt für die Möglichkeit der Stellungnahme. Für die Sitzung des EU-Rates Gesundheit vom 03.12.2024 haben 9 EU-Mitgliedstaaten ein Non-Paper zu Prioritäten bei der notwendigen Überarbeitung der EU-Verordnungen zu…

Consultation response

F. Hoffmann-La Roche Ltd, 20 Mar 2025

Our company welcomes the opportunity to give input on the IVDR/MDR targeted evaluation. The IVDR and the MDR are critically important Regulations to ensure access to safe and well performing products for the benefit of healthcare systems and patients in the EU and beyond. We fully support the goals…

Consultation response

European Blood Alliance, 20 Mar 2025

The European Blood Alliance (EBA), representing public and non-profit blood establishments in 29 countries in Europe, welcomed the MDR and IVDR and their decisive contribution to a more harmonised framework across Europe, which we believe can lead to an improvement in the quality and performance of…

Consultation response

Deutsche Krankenhausgesellschaft e.V., 19 Mar 2025

Die Neuregulierung des Medizinprodukterechts auf EU-Ebene war mit dem zu begrüßenden Ziel initiiert worden, die Patientensicherheit zu verbessern. Bereits im Rahmen der Verhandlungen wurde über den langwierigen Prozess hinweg von unterschiedlichsten Akteuren auf die drohenden negativen Konsequenzen…

Consultation response

SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V., 21 Mar 2025

The German Industry Association SPECTARIS welcomes the opportunity to give input to the targeted evaluation. The German medical technology industry has an annual turnover of circa 38 billion Euro and employs over 161.400 people, over 90% of companies are Small or Medium Enterprises. In short:…

Consultation response

Biomedical Alliance in Europe, 21 Mar 2025

Clinicians in Europe were among those who advocated for reform of the previous EU medical device directives which was initiated by a public consultation in 2009. However, in the current MDR & IVDR there are still some persisting challenges affecting healthcare in Europe. European medical societies…

Consultation response

Health Care Without Harm Europe, 20 Mar 2025

Health Care Without Harm (HCWH) Europe welcomes the opportunity to contribute to the European Commission's call for evidence on the evaluation of the Medical Devices Regulation (MDR). As a non-profit organisation dedicated to sustainable and harm-free health care, HCWH Europe also leads the Global…

Consultation response

Confindustria Dispositivi Medici, 20 Mar 2025

Confindustria Dispositivi Medici (CDM) welcomes the European Commissions initiative on the targeted evaluation of both medical devices (MDR) and in vitro diagnostics regulation (IVDR). We understand and support the general principles and process of the better regulation that MDR and IVDR are going…

Consultation response

European University Hospital Alliance, 19 Mar 2025

EUHA is a network of 11 leading European university hospitals renowned for their excellence in healthcare, education, research & innovation. The university hospitals we represent are committed to enhancing the quality of care, improving patient health and promoting well-being. EUHA recognises the…

Consultation response

European Hospital and Healthcare Federation, 21 Mar 2025

HOPE, the European Hospital and Healthcare Federation, is a European non-profit organisation, created in 1966 representing national public and private hospital and healthcare associations and hospital, health and social care services owners. With 36 organisations from the 27 Member States of the…

Consultation response

Erasmus Universitair Medisch Centrum Rotterdam, 21 Mar 2025

Within the Erasmus MC the Medical Technology Committee is responsible for the quality management system for safe development and application of medical technology within clinical research and clinical practice. We would like to address our concerns in line with the main concerns as presented by the…

Consultation response

Breakthrough T1D, 21 Mar 2025

Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments to the targeted evaluation by the Commission on the EU rules for medical devices and in vitro diagnostics. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research and advocacy organization,…

Consultation response

PETA Science Consortium International e.V., 21 Mar 2025

PETA Science Consortium International e.V. (the Science Consortium) welcomes the opportunity to comment on Regulation (EU) 2017/745 on medical devices (MDR) as part of the targeted evaluation launched by the European Commission. The Science Consortium promotes robust non-animal regulatory testing…

Consultation response

Brainlab AG, 21 Mar 2025

We are a medical device manufacturer of classes I, Is, Ir, IIa, IIb and III based in Germany. We have multiple MDR certificates and many product codes to maintain under MDR. While it was a long way to receive all these codes and a big investment to maintain the EU market access, we still struggle…

Consultation response

European Society of Radiology, 21 Mar 2025

The European Society of Radiology (ESR) welcomes the opportunity to submit a call for evidence on the evaluation of the Medical Devices Regulation. The evidence that follows is based on the experience prevalent in interventional radiologist units, which have been more affected by the shortcomings…

Consultation response

Hollandbio, 21 Mar 2025

Hollandbios reactie op de gerichte evaluatie van de EU-regels voor Medische hulpmiddelen en In-Vitro Diagnostiek Wanneer je ziek bent, wil je maar één ding: beter worden. Liever nog, blijf je gezond. De juiste behandeling op het juiste moment voor de juiste patiënt komt steeds dichterbij, dankzij…

Consultation response

Syndicat national de l'industrie des technologies médicales, 21 Mar 2025

Le Syndicat national de lindustrie des technologies médicales (Snitem) rassemble en France les acteurs de lindustrie des technologies et dispositifs médicaux y compris les entreprises impliquées dans le numérique en Santé. Il fédère plus de 600 entreprises françaises ou internationales dont la…

Consultation response

European Council of Optometry and Optics, 21 Mar 2025

As the European umbrella association representing the interests of optometrists and opticians across Europe, the European Council of Optometry and Optics (ECOO) fully supports the objectives of the MDR to ensure that medical devices placed on the market are safe. Opticians and optometrists…

Consultation response

TÜV SÜD AG, 21 Mar 2025

TÜV SÜD as a Notified Body designated under the EU MDR and EU IVDR fully supports the aim of the regulations to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.…

Consultation response

Masarykova univerzita, 26 Feb 2025

Compliance with MDR and IVDR regulatory requirements is difficult, especially for small and medium-sized companies, due to the complexity of the new regulation, the high cost of certification and testing, and the challenging clinical trials. For small companies with only a few employees and…

Consultation response

European Coalition to End Animal Experiments, 21 Mar 2025

Currently, in the Medical Devices Regulation (MDR) there is an absence of consistency with the aims expressed within Directive 2010/63 EU on the use of animals for scientific purposes; namely that the use of animals should be phased out by replacement as soon as possible and that the welfare of the…

Consultation response

Blood Transfusion Association, 21 Mar 2025

The BTA welcomes the ECs initiative to evaluate the EU regulatory framework for medical devices. While the MDR aims to ensure patient safety and high-quality healthcare, its current implementation presents significant challenges for blood bag sets, that are essential for safe blood collection,…

Consultation response

KARL STORZ SE Co. KG, 21 Mar 2025

Dear EC-Team, please see attached files also submitted to targeted evaluation but here with better resolution.

Consultation response

Medtech & Pharma Platform Association, 20 Mar 2025

We would like to bring to your attention the letter submitted by the Medtech & Pharma Platform (MPP) to the Commission in October 2024, which outlines key considerations ahead of the targeted evaluation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation…

Consultation response

Notified Body Coordination Group - Medical Devices, 20 Mar 2025

NBCG-Med supports the aim of the regulations to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. However, we welcome the improvement of the regulatory framework in the…

Consultation response

Pour Demain Europe, 19 Mar 2025

We welcome the Commissions evaluation of Regulations (EU) 2017/745 and 2017/746 and recommend integrating biosecurity safeguards and security by design principles for nucleic acid synthesis (NAS) technologies, particularly DNA synthesizers and benchtop devices. Addressing Biosecurity Risks:…

Consultation response

European Association of Flexible PU Foam Blocks Manufacturers, 19 Mar 2025

MedPharmPlast Europe (MPPE), sector group of European Plastics Converters (EuPC), appreciates the opportunity to contribute to the targeted evaluation of the EU rules on medical devices and in vitro diagnostics. We recognize the importance of a single EU Regulation, which provides a harmonized…

Consultation response

Laboratory Corporation of America Holdings, 19 Mar 2025

Labcorp is a global leader in diagnostics and drug development. It also has a presence across the EU, with facilities in Belgium and Germany and commercial staff across EU Member States. In Europe, we commercialise genomics assays and companion diagnostics (CDx). In addition, our central laboratory…

Consultation response

Verband der Diagnostica-Industrie, 17 Mar 2025

Die Stellungnahme des VDGH ist in der Anlage zu finden.

Consultation response

Association of Medical Device Reprocessors, 17 Mar 2025

On behalf of the Association of Medical Device Reprocessors (AMDR), the global non-profit trade association representing the regulated medical device reprocessing and remanufacturing industry, we appreciate the opportunity to contribute to the targeted evaluation of the EU Medical Device Regulation…

Consultation response

European Association of Nuclear Medicine, 14 Mar 2025

The European Association of Nuclear Medicine (EANM) appreciates the opportunity to comment on the call for evidence for an evaluation of the EU rules on medical devices and in vitro diagnostics. Please find attached the feedback of the EANM.

Consultation response

, 21 Mar 2025

BEAM Alliance represents 70+ European SMEs developing 120+ innovative products against antimicrobial resistance (AMR). AMR already causes 35,000 deaths in Europe and economic impacts that amount to billions, and these figures will continue to grow. BEAM aims to improve R&D environment, including…

Consultation response

European Federation of High-tech Industries, 21 Mar 2025

The European Federation eurom High-Tech Industries welcomes the opportunity to provide feedback to the Targeted Evaluation of the Medical Device and IVD frameworks. Medical Devices and IVDs are highly developed technologies that drive the European economy and ensure state-of-the-art healthcare for…

Consultation response

KCI Medical Belgium BV, 21 Mar 2025

About Solventum: Solventum (registered as KCI Medical Belgium BV in the transparency register) is a global healthcare company originating from the spin-off of 3M's healthcare business in 2024. The company employs over 22,000 people globally and has an annual revenue of $8.3 billion in sales in…

Consultation response

Avicenna Alliance, 21 Mar 2025

The Avicenna Alliance, a non-profit organisation which advocates for the adoption of in silico technologies during the regulatory approval process, welcomes the European Parliaments resolution which calls for measures to address the most pressing challenges and bottlenecks in the implementation of…

Consultation response

EUROMCONTACT, 21 Mar 2025

The EU Medical Devices Regulation (MDR) aims to create a robust legal framework that ensures only safe and effective devices are available on the EU market, to protect patient safety and public health while supporting innovation. EuromContact fully supports these goals and, 8 years after its…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 21 Mar 2025

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of over 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. For our community of patients, ensuring a high level of patient safety through a…

Consultation response

British Dental Industry Association, 20 Mar 2025

The British Dental Industry Association (BDIA) welcomes this targeted evaluation of the Medical Devices Regulation (EU MDR) and the Commissions recognition that action is needed to address the systemic challenges that have, since its implementation, jeopardised the availability of medical devices,…

Consultation response

SmiLe Venture Hub AB, 20 Mar 2025

Det nya regelverket för medicinteknik i EU har haft negativa konsekvenser trots goda intentioner om ökad patientsäkerhet. Det hämmar innovation, blockerar forskningsnära utveckling och hotar EU:s konkurrenskraft. Regelverket är oproportionerligt och lägger en tung börda även på lågriskprodukter,…

Consultation response

Bayerischer Industrie- und Handelskammertag, 19 Mar 2025

Der Bayerische Industrie- und Handelskammertag (BIHK) ist die Dachorganisation der neun IHKs in Bayern und vertritt das Gesamtinteresse der gewerblichen Wirtschaft (eine Million Unternehmen aller Größen) im Freistaat. Die BIHK begrüßt das Bestreben der Europäischen Kommission, den Rechtsrahmen für…

Consultation response

Information et défense des consommateurs salariés – Confédération générale du travail, 18 Mar 2025

Vous trouverez ci-joint l'avis d'INDECOSA-CGT (France)

Consultation response

European Hearing Instrument Manufacturers Association, 12 Mar 2025

The European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the revision of the Medical Device Regulation (MDR). EHIMA urges the European Commission to revise MDR implementation to ensure…

Consultation response

Bundesverband Medizintechnologie, 11 Mar 2025

Der Bundesverband Medizintechnologie e.V. (BVMed) begrüßt vollumfänglich das Bestreben der Europäischen Kommission, den Rechtsrahmen für Medizinprodukte und IVDs zu evaluieren und weiterzuentwickeln. Die beiliegende Stellungnahme und die dazugehörigen Anhänge wird sich vornehmlich auf die…

Consultation response

Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 21 Feb 2025

The AWMF is the umbrella organization of the scientific medical societies in Germany with 184 member societies, including the major specialist societies that perform in-vitro diagnostics. Our feedback is provided as a pdf-document.

Consultation response

Perpedes GmbH, 12 Feb 2025

Perpedes is a manufacturer of foot orthoses since 1927. Since an update to MDD 93/42 was required, the requirements of MDD 2017/745 were quite demanding and resulted in the retirement of some legacy devices. The goal of uniting the European market under one law was clearly missed. The protection of…