TÜV SÜD AG
As a technical services provider, for about than 160 years TÜV SÜD has been protecting people, the environment and property against technical risks, facilitating technological progress in the process.
ID: 433521917360-12
Lobbying Activity
Meeting with Felicia Stoica (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs) and TÜV-Verband e. V. and
19 Sept 2025 · Exchange on NLF, Market Surveillance Regulation and the Standardisation.
Meeting with Oliver Schenk (Member of the European Parliament)
10 Jul 2025 · Medical Device Regulation in the EU
Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation
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. However, the improvement of the regulatory framework in the medical devices sector to enhance harmonization, clarity and efficiency is welcomed to support this goal. The EU MDR and EU IVDR strengthen device quality, patient safety and transparency by encouraging closer monitoring of devices, including clinical and post-market aspects. In combina-tion with continued QMS oversight, device safety throughout the lifecycle is enhanced. Despite extensive efforts, the regulation's implementation has not been harmonized, resulting in varying degrees of strictness and national differences, creating an uneven playing field for all stakeholders. Further harmonization of the requirements for NBs and clearer guidance and fast decisions for regulatory topics (e.g. classification, borderlines, MDR Article 61(10)) are needed to create a level playing field and ensure consistency and efficiency in certification processes. Since the regulations came into force, many MDCG guidance documents have been published. However, some have been revised multiple times while essential topics remain unaddressed. Implementing these requirements demands significant resources, and the guidance documents are not always consistent with the regulations. There is little guidance available that sets out specific expectations regarding what data is necessary to meet the requirements of the regulations. This and the fact that the guidance documents are not legally binding and have no implementation deadlines, leads to time-consuming discussions between NBs and manufacturers. A great tool to set legally binding concrete expectations and enhance harmonization are the Common Specifications. This legal tool is currently underutilized and should be used more exten-sively. A clean-up and consolidation of existing guidance documents is recommended to reduce regulatory overload. Future guidance should be drafted through a harmonized, swift process with clear deadlines, allowing stakeholders sufficient time to adjust their processes. The language used in the regulations as well as the guidance documents is mostly very complex. A clearer and easier to understand language would help to interpret and comprehend the requirements for all stakeholders. Looking at the future, using a procedural approach when describing requirements would be beneficial to enable future digitalization, including moving from document to data assessment. This would increase efficiency of conformity assessments and duplicate review could be avoided. Currently, NBs cannot offer consultancy services under MDR/IVDR, but "structured dialogues" are allowed to enhance efficiency and predictability while maintaining independence. The organization and content of these dialogues are unclear, and early dialogue on product-specific questions is not allowed, leaving no opportunity for manufacturers to exchange product-related expertise. Clarification is required to specify permissible discussion topics and organization of structured dialogues. In addition, a process allowing early dialogue prior to the certification process would complement the structured dialogues and address the need expressed by the industry to answer product-related questions early on. Allowing procedural and scientific exchange can help to streamline conformity assessments, benefiting all stakeholders especially SMEs and innovative manufacturers. Cumulative application of MDR or IVDR and horizontal legislation to the same device could cause contradictory requirements. Integrating relevant provisions from horizontal legislation, especially those related to device safety, into MDR/IVDR could resolve this issue. See attachment for long version.
Read full response23 Jan 2023
Comments on the Appendix G TSI PRM Draft for passengers external doors audible signals. TSI regulations ought to provide technical requirements and may consider applicable technical standards for assessment. The proposal for Appendix G contents new measuring quantities (LS, LN, L1, L2, L3, LSmin, LSmax, LAeq20...) and test details compared to the Appendix G in 1300/2014/EU, which are not compatible to the referred standard EN 17285 for measuring of door audible warnings. Without technical need or prove of evidence the background noise LN shall be assessed as energy sum of three octave bands, because the A-weighting is sufficient for surrounding noise and the octave band filtering is implemented in Annex B of EN 17285 already. From technical experience regarding railway testing neither for the background noise estimation nor for door warning signals an energy equivalent level LAeq20 with an averaging time of 20s is needed. The duration of door opening and closing warnings are usually 5 seconds. While for surrounding background noise LN the LAeq is the applicable measuring quantity, for pulsed warning signals the quantity LAeq leads to higher sound levels than required for perception and to a lot of claims about noise disturbance by passengers and residents in the past. New requirements for door finding signals are presented in the draft Appendix G without essential feedback from test labs or acoustic experts of CEN/TC 256. Due to an undesigned alternation of the measuring distance from 0.1m to 1.5m the door finding sound levels by principle increase about 20 dB compared to projects already implemented. For adaptive signal tests the background noise appears at the same time as the warning/finding signal which lead to energy sum of both signals on the receiver. Hence, by use of LAeq quantity for pulsed signals it is difficult to assess the criteria LS LN + 5 dB and impossible to assess LS LN 5 dB. According to psycho-acoustic basics of human perception, experience of test labs and the EN 17285 standard sound levels of pulsed warning signals should be measured by the LAFmax. A change of the measuring quantity LS for pulsed signals to LAFmax would align TSI PRM requirements with the test method and would avoid a lot of discussions in type tests and homologations. As long as the context of Appendix G does not provide the information that door warning signals are applicable inside and outside of rail cars, the header "passengers external doors audible signals" (Einstiegstüren oder äussere Warnsignale, GER) can be ambigiously in translations.
Read full response25 Oct 2017
Comments to the draft Implementing Act regarding IVDR codes
The IVDR codes proposed in annex II of the draft implementing act create a 5 dimensional system consisting of design/purpose related codes (1st dimension) and 4 horizontal dimensions of codes to cover all types of IVD devices. In total 100 IVDR codes are defined.
Beyond the pure number of codes the 5 dimensional approach creates a complexity which is hard to be handled adequately by both sides competent authorities and notified bodies. In addition, the draft implementing act leaves it open how the IVDR codes shall be applied in practise, which is essential for implementation. This may counteract harmonization in the designation process already achieved by use of joint audit teams.
There is reasonable overlap between the IVR codes (design/purpose of the device) and the IVD codes (laboratory and clinical disciplines) which makes it difficult to distinguish between the required qualifications for the respective codes. Same applies to the IVP codes (examination procedures) and IVD codes (laboratory and clinical disciplines). Furthermore, the definition of 30 IVD codes reflecting laboratory and clinical disciplines, 10 of them in the field of virology, creates an impractical level of detail.
In contrast 71 MDR codes as proposed in annex I of the draft implementing act in 3 dimensions are obviously considered sufficient to depict the high diversity of medical devices which include diagnostic as well as and therapeutic devices.
It is recommended to abstain from at least one dimension of this coding system for IVD and considerably reduce the number of laboratory and clinical disciplines.
Read full response