Today, 23 October 2024, the European Parliament votes in favour of a resolution to update the Medical Devices Regulations within 180 days. The motion passed with 545 votes in favour, 80 votes against, and 15 abstentions. On the other hand, the motion for a centralised governance structure did not pass.
Resolution for urgent update of MDR and IVDR
With resolution 2024/2849(RSP), the Parliament agreed on the following:
- Calls on the Commission to propose, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible;
- Calls on the Commission to make full use of legislative and non-legislative tools to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety;
- Deplores the risk of shortages of medical devices and the lack of access to certain medical devices and in vitro diagnostics in parts of the EU; stresses that access to and quality of healthcare, including medical devices and in vitro diagnostics, should not depend on where in the EU a patient is located;
- Encourages the notified bodies to ensure that there are sufficient resources to meet the market demand in a timely manner; in this regard, calls on the Commission and the Member States to enhance support and cooperation to ensure that the notified bodies have the optimal capacities and capabilities to fully implement the regulatory framework;
- Advocates the creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies, thus creating predictability and certainty for manufacturers regarding the market access procedure and its duration within the EU;
- Calls for transparency in notified bodies’ fees and fee structures, to allow economic operators to compare notified bodies and make informed choices, ensuring that fees remain a fair compensation for the public service provided;
- Stresses the need to eliminate the unnecessary re-certification of products, and underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification of the product; stresses the need to harmonise such provisions and ensure consistency across the EU; calls for cooperation between the competent authorities and advisory bodies responsible for other regulatory frameworks, and stresses the need for products to be classified correctly and consistently;
- Strongly calls on the Commission to consider fast-track and prioritisation pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies;
- Highlights the need to establish a clear working definition of ‘orphan device’, as determined by the Medical Device Coordination Group in the MDR and IVDR, to facilitate the adoption of harmonised measures across the EU; additionally calls for a robust system to prevent misuse through artificial ‘orphanisation’;
- Calls for the introduction of adapted rules for orphan and paediatric medical devices, without compromising patient safety, and emphasises the need for more efficient conformity assessment procedures tailored to medical devices and in vitro diagnostics serving relatively small markets, such as products for the treatment of children or rare diseases;
- Calls on the Commission to facilitate the collection of clinical data from existing national registries for small patient groups treated or diagnosed with orphan and paediatric devices, in compliance with the protection of personal data; recognises the challenges faced by various SMEs in adapting to the legal frameworks; invites the Member States and the Commission to develop specific measures to support SMEs, including the provision of model application documents and forms, regulatory guidance and other assistance to reduce the costs and complexity of the regulatory frameworks;
- Calls on the Commission to continuously monitor the availability of devices, particularly the last remaining devices of particular types, and to take appropriate action to keep them available in the EU market; in this regard, calls for an urgent full implementation of EUDAMED, which will enable information about medical devices and manufacturers to be processed to enhance transparency, provide better access to information for the public and healthcare professionals, and enhance coordination between Member States;
- Emphasises that any new rules or changes to existing rules must come with an appropriate transition period to allow all stakeholders sufficient time to adjust to the changes;
- Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.
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I am a small MED DEV designer manufacturer in the Respiratory and Pulmonary Function healthcare market. I have sold my devices as MED Devices into the EU market since the 70’s. This means I had several Tech Files (10) of legacy devices sold into this market. All of these devices were Class I & IIa. We met all the requirements of the MDD for many years thru our NB Semko then BSI and our certification to ISO 13485. Once the new REGS re. MDR came due we had to switch approaches because of the cost to meet the REGS for TF development etc. We have now met the MDR and are certified but had to eliminate most all of our legacy devices and now only have one Class IIa TF and two Class I TF’s. The cost to generate the Class IIa TF along with the cost to meet all the new 13485 MDR QMS REGS was rediculous on the order of a 500% increase and the loss of lots of devices that can ship as MED DEVs into the EU. The TF that was a Class IIa was several series of our face masks for NIV, CPAP, Exercise Testing and Emergency – these are Face Pieces. The TF that was sent to BSI for these face masks was 7000 pages and took almost 2 years to be approved. We are 42 persons and now have 3 quality engineers on staff and have to resort to outside services as well to fullfill certain TF requirements like the CER etc. Just finished a RECERT AUDIT to the MDR 13485 that cost us $38K just for the AUDIT. Since we started this MDR process we have had several BIOCOMP audits, several surveillance audits and unannounced audits. The COSTS are prohibitive for a small MED DEV MFG. What you are proposing NOW is TOO LITTLE TOO LATE as most all the DEV MFG’s like us have made their BIZ decisions and movements and cannot reverse the process. The SMALL DEV MFG is the majority by far of the MED DEV manufacturers – that is the market and the MDR was designed to eliminate the SMALL MED DEV companies.
Dear Mr. Kevin,
Thank you for your comment.
We understand the challenges that the current regulation is presenting for the industry. The Commissioner-designate for Health and Animal Welfare, Mr. Oliver Valhelyi, has announced in his hearing speech that he will launch a revision of EU medical devices legislation. Therefore, we encourage you to share your insights with the European Commission once the Targeted Evaluation of the MDR is officially open for public comments, which we expect to happen soon. This could allow your perspective to be considered in shaping future regulations.
We keep all MDlaw members informed through our News section on any new regulatory updates in the Medical Devices sector for the EU and UK. If you are interested in learning more about our memberships and how they provide ongoing regulatory insights and support, please feel free to reach out. We would be happy to assist you.
Best regards,
Meric, MDlaw team