Serious medical device shortages in Germany have been observed – and more are expected – as a consequence of the new EU regulation for medical devices (MDR).
New MDR
Since 26 May 2021, manufacturers have to adhere to the new EU MDR, which included a reform for the certification of medical devices.
This new MDR replaced the existing processes for the launch and supply of medical devices that were established over decades.
Consequences of the MDR
The new regulation means that an estimated 55,000 medical devices that are already on the German market have to be re-certified by 26 May 2024. But this re-certification often requires clinical data that have never been collected.
Therefore, the medical device industry and medical societies warn that these re-certification requirements lead to supply medical device shortages and withdrawals in Germany.
In addition, the MDR also negatively impacts the development of new medical devices. According to a survey of medical device manufacturers, 46% put their innovation projects on hold. 19% are launching their products first outside the EU, in the US or Asia.
Reactions of the EU Commission
The coordination group for medical devices (MDCG) at the EU Commission now wants to introduce measures to facilitate the move to the stricter EU regulations and to avoid shortages.
- With the EU MDR, the certifications of new and re-certifications of existing medical devices are conducted by so-called “notified bodies”. However, with the MDR, all existing notified bodies first also have to be re-certified themselves. The MDCG recommends that notified bodies use hybrid audits and structured dialogues with the manufacturers to increase the efficiencies in the assessment process.
- Additional support will be offered to small or medium-sized businesses.
- The MDCG will also review their guidelines. They aim to identify where the documentation and administrative effort for the notified bodies can be reduced.
Reactions at the national level
Federal States
There are also efforts at the national level to stop the expected medical device shortages: the Federal States of Bavaria and Baden-Wuerttemberg want to set up an initiative at the German Federal Council to improve the implementation of the MDR.
They have already observed 6,000 cases of medical device withdrawals from the German market. Often they are niche products – orphan devices, such as cardiac catheters for babies. So these withdrawals are actually risking lives!
The initiative at the Federal Council is aimed to:
- offer solutions, especially for important niche products, whose production has become uneconomical due to the small number of patients and sales in relation to the high certification costs
- provide support and relief for existing medical device products
- increase capacities at the certifying notified bodies
- name new notified bodies and
- simplify and accelerate the certification procedures for new and innovative products, especially for small- and medium-sized businesses.
The Federal Council has now appealed to the Federal Government to work at the European level to improve the implementation of the EU MDR.
Federal Government
The Federal Government states that they are in close contact with the European partners in order to identify and solve the problems that have arisen as a result of the introduction of the MDR.
The German Health Minister, Karl Lauterbach, wants to achieve an extension of the transition phase beyond May 2024.
Further reading related to medical devices
- Will the EU regulation for medical devices result in withdrawals or shortages?
- Happy with your knowledge on the reimbursement of medical devices in Germany?
- 8 NUB assessments of high-risk medical devices (§ 137h)
- The process of method assessments in Germany
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