Mölnlycke supports the European Institution’s effort of using an accelerated process to adopt the proposed amendment to the MDR
Mölnlycke expects to be MDR compliant in line with the original timeline - but supports the proposed extended MDR transition period in order to protect patients from medical devices disappearing from the market
More than five years ago, Mölnlycke initiated the work to plan for compliance in accordance with the Medical Devices Regulation 2017/745 (MDR). We have since then been able to achieve certification under the new legislation for the majority of our products and we expect to be ready in accordance with our original transit plan. Therefore, we anticipate that the availability of Mölnlycke products and solutions in the EU will remain unaffected by the legislative actions that are being initiated.
“Mölnlycke believes medical device manufacturers have a great responsibility to society, including to support European health systems to provide safe and effective products for health care professionals to care for patients leading to improved quality of life”, comments Mölnlycke’s CEO Zlatko Rihter.
The EU regulation MDR 2017/745 entered into force in May 2017 and the date of application was originally set to May 2020. The European Commission granted an additional year until May 2021 but the extra year did not influence the transitional dates -- meaning the last day for placing products on the market under the old legislation (MDD) still remained the same i.e. May 2024, provided the manufacturer has a valid MDD certificate. The products placed on the market under MDD before May 2024 could also be “sold out” until May 2025. The expected amended proposal aims to extend the transitional period in a staggered way as well as remove the sell-off period end date.
“We recognise that macro-economic events, such as the post-pandemic situation and the conflict in Ukraine, have caused disruption to access to high-quality care for patients. Mölnlycke as a Group, represented by me as its CEO, and in line with the ‘Medical Devices Regulation Intended Benefits of the new CE Marking Regime’ recently released by MedTech Europe, see the implementation of the MDR to ensure patient safety in the health systems of the European Union as critical. In order to maintain access to existing devices, and not put patients at risk, Mölnlycke will continue to invest and prioritise compliance with the regulation”, comments Zlatko Rihter.
Mölnlycke supports the European Commission’s recognition of the ongoing urgent risks of medical device shortages in Europe, stemming from the MDR implementation challenges. Mölnlycke accepts that, regardless of its own readiness, the amendment of the transitional measures in MDR is required to ensure the continuation of the supply of medical devices.
Therefore, Mölnlycke welcomes the effort of the European Union Institutions of using an accelerated process to adopt the proposed amendment to the MDR. Mölnlycke hopes the expected amended proposal will help address the challenges related to the MDR implementation for the benefit of patients and health systems.
Mölnlycke have successfully been able to CE mark the majority of our product ranges in accordance with MDR based on our new Certification. We expect to be ready with the remaining products and solutions before our MDD Certificates expire and will focus on new innovations. Mölnlycke would like the efforts of those companies who were ready to meet the original deadline of May 2024 to be recognised given the diligence and resources they prioritised to achieve this.
Please see more information here: What is MDR ( Medical Device Regulation)? | Mölnlycke (molnlycke.com)
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Director Corporate Communications
Phone: +46 708 28 33 39