Changing medical device market: challenges and opportunities through MDR adaptations!
Alongside the pharmaceutical industry, the German medical technology sector, with an annual turnover of 40.4 billion euros and an export rate of 68%, is another mainstay of the German economy and represents an important part of national healthcare. However, since Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR), came into force, the industry has faced considerable financial and capacity-related challenges.
Small and medium-sized companies are particularly affected by this. The MDR requires specific adjustments to internal processes and revisions to regulatory documentation, which is pushing many companies to their limits. The situation has been exacerbated by capacity bottlenecks at the notified bodies. Where certification used to be possible within a few months, the procedures now often take 18 to 24 months. Added to this are increased documentation requirements, which cost both time and money.These delays lead to an innovation backlog and threaten the market launch of new, urgently needed products. Experts estimate that up to 30% of all medical devices could disappear from the market - and in some cases already have - if the process is not accelerated.
In order to better understand the impact of the MDR, several studies are currently being conducted, including the “Study on Regulatory Governance and Innovation in the field of Medical Devices” by EY Belgium on behalf of the European Commission.
Initial results show that Regulation (EU) 2017/745 has helped to significantly improve safety standards for medical devices in Europe. The stricter requirements for clinical data and certification have created a more robust and consistent safety environment, which has led to increased confidence among patients and healthcare providers. At the same time, however, these requirements also bring challenges, especially for small and medium-sized companies, such as longer certification processes, higher costs and the increased administrative burden, which makes it more difficult for companies to bring their products to market quickly.
In addition, the Directorate-General for Health and Food Safety (DG SANTE) has commissioned a study on the availability of medical devices on the EU market. This study shows that despite the challenges mentioned above, 63% of manufacturers have already successfully made their products available both inside and outside the EU. This underlines the industry's adaptability and commitment to meeting regulatory requirements.
In order to make the MDR both safety and innovation-friendly, the findings from these studies are of crucial importance.
Extended transition periods: a step in the right direction!
Despite everything, an important step has already been taken to ease the burden on the industry: In January 2023, the European Commission decided to extend the deadlines for compliance with the MDR requirements. Manufacturers of high-risk products now have until the end of 2027, while medium- and low-risk products must comply with the MDR requirements by the end of 2028. This deadline extension gives companies strategic leeway, which they should use to achieve MDR compliance and secure their market presence.
In addition, further adjustments have been made, in particular to identify gaps in supply at an early stage and finally use a Europe-wide digital tool that is intended to stand for harmonization, less bureaucracy and agility. The EUDAMED modules, which must be used from the end of 2025 in accordance with Regulation (EU) 2024/1860, will be introduced gradually. In addition, Article 10a has been included in the MDR, which defines specific obligations for manufacturers in the event of an interruption in the supply of medical devices.
The European Parliament calls for a swift improvement of the MDR!
Recently, on October 23, 2024, the European Parliament adopted a resolution calling for an urgent revision of the MDR to ensure patient care and improve the competitiveness of the medical technology industry, especially small and medium-sized enterprises (SMEs). The resolution emphasizes the following key points:
- Submission of delegated acts by the end of Q1 2025.
- Transparent, binding timelines and fees for conformity assessment.
- Introduction of fast-track procedures for innovative products and specific regulations for orphan and pediatric medical devices.
- Elimination of unnecessary recertifications and bureaucracy.
- Special support for SMEs.
These demands are intended to ensure that the MDR not only meets strict safety requirements, but is also designed to be more innovation-friendly and practical. The aim is to improve the availability of medical devices and relieve the burden on small and medium-sized enterprises in particular in order to strengthen the competitiveness of the medical technology sector. Don't wait for measures to adapt the MDR: avoid further bottlenecks and secure market access!
Although the European Parliament is calling for a swift revision of the MDR, companies must act immediately to avoid falling into the second wave of bottlenecks.
Now is the right time for companies to actively use the expanded capacities of notified bodies. These additional and now free resources offer a valuable opportunity to complete the certification process more efficiently and in a timely manner. Companies should strategically take advantage of this opportunity and not wait for further amendments to the MDR. Comprehensive and useful changes will not be able to intervene in the process soon enough to avoid a second wave of bottlenecks. Proactive action is needed to obtain MDR certification and secure market access.
Given the capacities of the notified bodies, it is also advisable to seek contact at an early stage and discuss potential stumbling blocks in order to avoid delays in the certification process and make profitable use of the current opportunities.
TentaConsult: The experts at your side for MDR compliance!
These are turbulent times for the European medical technology industry, but they also offer opportunities. It is crucial that companies use the extended deadlines to make the technical documentation for their products MDR-ready and start the conformity assessment procedure without pressure.
TentaConsult Pharma & Med offers comprehensive support in the implementation of the MDR. Our experts accompany you in all phases - from the initial gap analysis of existing data, to the identification and assessment of risks, dealing with contract manufacturers, supplier audits, analysis and assessment of biocompatibility and verification of efficacy and safety in the course of clinical evaluation.
Do you still need clinical data to support efficacy claims? Then we can support you in identifying relevant clinical parameters and finding a suitable study design for you. Strengthen the future of your products in competition and secure your market presence!
Let's work together to turn the challenges of the MDR into opportunities and actively shape the future of medical technology.
contact
Address Münster:
TentaConsult Pharma & Med GmbH
Wienburgstr. 207
48159 Münster, Germany
Phone: +49 251 928 715 60
info@tentaconsult.de
Address Martinsried:
TentaConsult Pharma & Med GmbH
Fraunhoferstr. 9
82152 Planegg/Martinsried, Germany
About TentaConsult Pharma & Med GmbH
TentaConsult Pharma & Med GmbH, based in Münster and Munich, is a consulting company for the pharmaceutical and medical device sector. Under the umbrella of the Tentamus Group, TentaConsult has a clear focus on comprehensive services and consulting in all aspects of regulatory affairs, quality management, clinical & medical affairs, vigilance & surveillance - for both medicinal products and medical devices.
The company supports its clients in meeting the regulatory requirements for bringing medicinal products, medical devices, nutraceuticals and cosmeceuticals to market and ensuring their marketability - not only in Germany, but also in Europe and worldwide. TentaConsult attaches great importance to the feasibility and cost-effectiveness of its clients' projects.