Even if the Kremlin wants to give the opposite impression: concerns about a Russian invasion of Ukraine continue to grow. “These episodes that heralded an apparent de-escalation are not being taken seriously at the moment,” said Italian Prime Minister Mario Draghi after the special meeting of EU leaders on the sidelines of the EU-Africa summit. Now it is important for the West to stand firmly together and not show any weakness. In a joint statement, Germany, France, and other European allies sharpened their tone toward Russia.
The Regulatory Scrutiny Board (RSB) advises the Commission members on the preparation of legislative initiatives and checks the quality of the impact assessment of the planned legislative texts – quite independently of other institutions, agencies, and lobbyists. This is true even though in the case of the supply chain law, there are doubts about that very independence. The body’s working methods are also anything but transparent. Bernd Lange, Chairman of the Trade Committee in the European Parliament, recently even spoke of a “secret body”. Charlotte Wirth explains the background.
Many of the members of the German Association for the Digital Economy (BVDW) come from the online advertising industry. The Digital Services Act – if it were to be passed in the current parliamentary version – would probably cause them problems. BVDW President Dirk Freytag and Vice President Thomas Duhr warn of regulatory chaos in an interview with Falk Steiner.
An alliance of environmental and social organizations and churches is calling for the per capita redistribution of the revenue from CO2 pricing to be introduced as quickly as possible. According to a study, the course has already been set so that the “climate premium” could be implemented before the end of this legislative period. Read more about this in the news.
Actually, Bernd Lange should not even be aware of the paper. The opinion of the Commission’s internal Regulatory Scrutiny Committee on the EU Supply Chain Act will, as usual, only be made publicly available once the Commission has adopted the corresponding legislative proposal. But Lange, the chairman of the European Parliament’s Trade Committee, has obtained the opinion in advance: “It is very political,” the Social Democrat notes.
The Regulatory Scrutiny Board (RSB) reviews the quality of impact assessments of proposed legislation. In the case of the Supply Chain Act, the RSB issued two negative assessments. The reasons are known only to those to whom the opinions were leaked. One thing is certain, however: the opinions have led to significant delays. The college is now scheduled to adopt the Due Diligence Law for companies on February 23th (Europe.Table reported) – more than a year late.
“This shows how much power the RSB has,” said Tiemo Wölken (S&D) in January at the presentation of his initial report on Better Regulation. In Parliament, one is certain: the body has exceeded its mandate, at least with this law. “It would be absurd if the planned law were now watered down because a non-transparent, technical body interferes in political decisions,” says German Green MEP Anna Cavazzini, shadow rapporteur on the Supply Chain Act in the Trade Committee. Bernd Lange also finds clear words: The RSB has become a “political assessment body” and has taken up the argumentation of Business Europe, a business association.
The body has so far been working largely in the dark. Jean-Claude Juncker set up the body in 2015. The then Commission President wanted to strengthen the then “Impact Assessment Board” and improve the quality control of legislative texts. As an independent body, the RSB is to advise the College and the Commissioners on the preparation of legislative initiatives. The Board also reviews impact assessments and evaluations for proposed legislation. It is composed of seven experts – four Commissioners and three Associate Experts.
In 2020 alone, 46 percent of impact assessments received a negative rating. The reason: “In many cases, the Commission takes too little time to adequately prepare and carry out impact assessments,” says the 2020 annual report.
If an impact assessment receives negative feedback, the Commission must improve the text and resubmit it. Two negative assessments, as in the case of the Sustainable Business Act, are extremely rare. In 2020, there was only one such case, and that was the impact assessment for a directive on equal pay for women and men. In this case, the Commission was exceptionally allowed to submit the text a third time and was given the green light.
However, the Commission can also bypass the panel in the case of two negative assessments: To do so, it needs the approval of the Deputy Commissioner for Institutional Relations and Foresight, Maroš Šefčovič – as happened with the Supply Chain Act. The law must then state the extent to which the Commission has taken the RSB’s criticisms into account. It can therefore also skip the evaluation of the RSB.
According to the statutes, the committee must act completely independently and autonomously. Members may not follow instructions from other institutions or agencies and may only meet with registered lobbyists.
So much for the theory. In practice, the composition of the committee alone is problematic. With seven members, four of them Commission officials, it is difficult to speak of an independent, autonomous body, criticizes Tiemo Wölken: “The EU officials always have the upper hand.”
In addition, the RSB has not been fully staffed for at least two years. In 2020, the board had only four members, and in some cases only three, as shown in the corresponding annual report. With only three members, the board was not able to function at all for three months.
The Commission seems to have particular difficulty in recruiting external members, who are selected on the basis of their academic performance in the field of impact assessments and regulatory policy. Even currently, only two experts are assigned to the RSB. Recruitment of a third member is “ongoing,” according to the commission. However, the search has been ongoing since the end of 2020, as can be seen from the relevant annual report.
This makes the preponderance of Commission officials even clearer. The quorum is four members, and in the event of a tie, the chair’s vote is decisive. According to the rules of procedure penned by current Chair Veronica Gaffey, formerly Director of the Commission’s Individual Claims Determination and Resolution Office (PMO), the principle of collective responsibility applies to RSB members: members may not question the decisions. However, this also means that the external members are bound by the decisions of the Commission officials. The officials could overrule the external experts on any vote.
The technical composition of the members also raises questions. According to the Commission’s decision, committee members must have expertise in macroeconomics, microeconomics, social policy and environmental policy, i.e. the three pillars of sustainable development. This is becoming increasingly relevant, especially against the background of the Fit for 55 package, even the RSB writes in its annual report.
However, if you look at the curricula vitae of the current members, only economists and financial experts sit on the committee. Only one economist with a focus on climate and environmental policy was a member until 2021: Andreas Kopp, who is now working again as a scientist at the think tank CEPS. This has also come to the attention of the EU Parliament, as can be seen from a parliamentary question by Green politician Anna Cavazzini.
The MPs also consider the transparency of the RSB to be insufficient. At a hearing of the Trade Committee, Bernd Lange spoke of a “secretive body” that was acting undemocratically. The SPD politician had tried to invite an RSB representative to the hearing to discuss the opinions on the Supply Chain Act. The panel declined. Instead, the Director-General of Commerce, Sabine Weyand, attended the meeting. But she did not answer a single question about the RSB.
The situation is similar for anyone who wants to access the panel’s assessments. For example, the Commission rejected the access-to-documents request of a researcher who had asked for opinions on the Supply Chain Act. The reason given was that these were documents relating to a decision that the Commission had not yet taken.
The Commission also rejected requests for meetings between RSB members and stakeholders on the grounds that the relevant documents did not exist. This is what happened, for example, in the case of an inquiry from Lobbycontrol about the Digital Markets Act. Only the lobbyist meetings of the RSB chairs are published.
According to the statutes, members “may not discuss individual dossiers that directly affect stakeholders,” but may only provide an overview of the body’s work. It is striking that Chairwoman Gaffey has met almost exclusively with business representatives over the past three years, most recently with the European industry association Business Europe. This does not say anything directly about the content of the discussions, but it does show that business associations have privileged access to the RSB.
However, a meeting with the French Association of Private Companies in 2020 raises eyebrows: whereas on January 17th it simply read that the association had asked for a meeting to discuss the supply chain law, ten days later the Commission added to the entry that “the chair of the RSB did not discuss the proposed law, but provided a general presentation of the body.” At the very least, this shows that the meetings are problematic in terms of maintaining the independence of the committee.
The RSB’s assessments are to be publicly available the moment the Commission publishes the corresponding legislative initiative. But to do that, you have to track down the documents first. The RSB assessment of the Digital Services Act, for example, is difficult to find. In the relevant legislative text, there is only a footnote stating, “Links to the summary and favorable opinion of the Regulatory Review Board will be included after they are published.”
Only via the register of Commission documents can the relevant decision be found. Moreover, the opinion is not complete. It refers to “technical comments” that the Board sent directly to the author of the impact assessment. These comments are not public.
Commission President Ursula von der Leyen now wants to reform the body to some extent. On March 1st, the current Director-General for Translation, Rytis Martikonis, will take over the chair from Gaffey. In the future, the committee will also examine the implementation costs of legislative initiatives and take into account strategic considerations as well as the effects of the COVID-19 pandemic.
In addition, von der Leyen would like the body to provide better information about its role in the legislative process. In this way, she wants to strengthen trust in the commission. Tiemo Wölken demands that at least the opinions be accessible immediately and not only when the laws are presented: “The current cat-and-mouse game does not help trust.”
Mr. Freytag, Mr. Duhr, parts of the digital economy are currently under enormous regulatory pressure. The effects of the General Data Protection Regulation are becoming more visible, and the supervisory authorities are more eager to make decisions.
Dirk Freytag: In principle, it is to be welcomed that the protection of consumer privacy is also enforced in accordance with the regulatory framework. We have formed many groups and working groups in our association to protect privacy and still enable business models. There must always be a balance between the two areas. However, we are in the unfortunate position that certain elements are still not there today that should actually come along with the GDPR. We, therefore, keep operating in a half vacuum. And now it is the interpretation of a legal framework that is not completely clear.
Do you mean the e-privacy regulation, which was supposed to come into force in parallel with the GDPR in 2018? You can see, for example, from the decisions of the CNIL supervisory authority in France, that this has explosive power.
Thomas Duhr: The simultaneous entry into force of the e-privacy regulation was an extraordinarily ambitious goal and actually not possible from the outset. We are currently seeing that many of the elements envisaged for this are being incorporated into numerous other legal frameworks on the part of the European Union. Parts of it can now be found in excerpts in the Digital Services Act, other parts in set pieces in the Digital Markets Act. And it is very likely that we will also find excerpts in the Data Act and Data Governance Act. In other words, we are running into a legislative structure of Babylonian proportions. With the great danger that the legal framework at the European level will end in a single prank.
That more or different regulation is necessary, I don’t think you’ll doubt.
Duhr: It is essential that the European Union sets out to further develop the digital economy with a set of rules – this is what the economy and consumers need. However, we are currently seeing an excess of activity without proper reflection and a review of the most recently introduced projects for their respective effects.
The General Data Protection Regulation, in force since 2018, has not yet been sufficiently illuminated in all its effects and facets. We would rather see such a set of rules being developed further than additions with unclear scope being herded through the village like swine. The multitude of legal acts makes it impossible for almost any market participant to even understand where they are and where they are going. This does not lead to a strengthened digital economy in the European Union. Rather, it leads to a digital Schilda.
The DSA is intended to stop some controversial practices. For example, the parliament wants to forbid the data-based targeting of minors. What do you criticize about this?
Duhr: It doesn’t belong in there. The GDPR regulates the processing of personal and personally identifiable data. With sets of rules for processing children’s data, the overall power of the GDPR is diluted. The current objective achieves exactly the opposite in real terms. How do you want to make it possible for a market participant, a website operator, to avoid violating the law? This can only be done if you distance yourself from the dictum of data minimization and data economy and a complete identification of each individual user and usage process takes place. This leads not to less data, but to more.
This would mean that I can never determine whether it is a child using the internet without having already processed his or her data. What would be the consequence?
Duhr: That every website you know today has to have a hard authentication upstream so that this website can be used at all. And I’m talking about every website, every institution, every authority, a company, a private individual. That is, I think, an internet that we can’t imagine like that.
Proponents say the regulation only targets tracking and in the end “only” the business model of tracking-based, ad-supported websites would be threatened …
Duhr: It is a misconception that tracking is a technology that is used exclusively for the issue of advertising financing. I need tracking to collect performance data, to analyze the use of my individual offering, to individualize my offering. I also need tracking technologies, correctly, to play out more specific advertising. However, it is a variety of the same technology that is needed for all other purposes in order to offer digital services on the internet.
There is a lot criticism of the business community for their attempts to persuade users to give their consent via cookie banners and “dark patterns. consent via cookie banners and dark patterns. The proposals that are now on the table aim to reduce the room for maneuver here. Has the digital economy overreached in the past?
Duhr: (Long pause) The criticism that people have exaggerated is certainly correct. As in almost all industries, there are also black sheep in the digital economy. But the reaction on the part of legislators cannot be to stipulate by law that every entry area to every department store, to every business, is absolutely identical. That is the opposite of what should actually be achieved.
You can read more about how Dirk Freytag and Thomas Duhr from the BVDW look at the DMA, the Privacy Shield debate, and the new German government on our website.
The MDR is a watershed. The requirements for market access of medical devices, for the life cycle of the product, and for notified bodies are increasing significantly. The new regulatory framework affects not only new medical devices, but also all proven and safe existing products, as well as specialty products, such as those for small patient populations. All Notified Bodies must go through a lengthy European designation process. The review time for the more extensive files is significantly increased.
The new EU regulation is already having a drastic impact on the medical technology market. BVMed conducted a survey on this in the fall of 2021, in which 88 member companies participated. More than 70 percent of BVMed member companies have already discontinued individual medical devices or entire product lines due to the new regulations brought about by the EU Medical Devices Regulation (MDR). Over 55 percent of the BVMed companies surveyed stated that previous suppliers had already discontinued their business activities due to the MDR.
Almost nine months after the MDR came into force, the medical technology industry is still ready, but the system is not. There is still a dramatic capacity bottleneck at the notified bodies. There is a threat of a huge backlog of certificates in the next few years due to scarce resources that need to be put to better use. And not only that: innovations are coming to a standstill because research departments currently have to focus on the MDR regulations.
The pressure to act is growing. Notified bodies must channel and better utilize their capacities, focus on QMS audits and reviews of technical documentation in order to clear the certification backlog. In addition, pragmatic solutions must be established for existing and niche products.
BVMed sees the following possible solutions:
Conclusion: If SMEs are forced to shift their R&D resources to regulation at the expense of innovation activity, this shows that MDR has overshot the mark. We, therefore, need to develop MDR strategically. Companies, hospitals, and physicians are all in the same boat when it comes to care and safety.
Even if the Kremlin wants to give the opposite impression: concerns about a Russian invasion of Ukraine continue to grow. “These episodes that heralded an apparent de-escalation are not being taken seriously at the moment,” said Italian Prime Minister Mario Draghi after the special meeting of EU leaders on the sidelines of the EU-Africa summit. Now it is important for the West to stand firmly together and not show any weakness. In a joint statement, Germany, France, and other European allies sharpened their tone toward Russia.
The Regulatory Scrutiny Board (RSB) advises the Commission members on the preparation of legislative initiatives and checks the quality of the impact assessment of the planned legislative texts – quite independently of other institutions, agencies, and lobbyists. This is true even though in the case of the supply chain law, there are doubts about that very independence. The body’s working methods are also anything but transparent. Bernd Lange, Chairman of the Trade Committee in the European Parliament, recently even spoke of a “secret body”. Charlotte Wirth explains the background.
Many of the members of the German Association for the Digital Economy (BVDW) come from the online advertising industry. The Digital Services Act – if it were to be passed in the current parliamentary version – would probably cause them problems. BVDW President Dirk Freytag and Vice President Thomas Duhr warn of regulatory chaos in an interview with Falk Steiner.
An alliance of environmental and social organizations and churches is calling for the per capita redistribution of the revenue from CO2 pricing to be introduced as quickly as possible. According to a study, the course has already been set so that the “climate premium” could be implemented before the end of this legislative period. Read more about this in the news.
Actually, Bernd Lange should not even be aware of the paper. The opinion of the Commission’s internal Regulatory Scrutiny Committee on the EU Supply Chain Act will, as usual, only be made publicly available once the Commission has adopted the corresponding legislative proposal. But Lange, the chairman of the European Parliament’s Trade Committee, has obtained the opinion in advance: “It is very political,” the Social Democrat notes.
The Regulatory Scrutiny Board (RSB) reviews the quality of impact assessments of proposed legislation. In the case of the Supply Chain Act, the RSB issued two negative assessments. The reasons are known only to those to whom the opinions were leaked. One thing is certain, however: the opinions have led to significant delays. The college is now scheduled to adopt the Due Diligence Law for companies on February 23th (Europe.Table reported) – more than a year late.
“This shows how much power the RSB has,” said Tiemo Wölken (S&D) in January at the presentation of his initial report on Better Regulation. In Parliament, one is certain: the body has exceeded its mandate, at least with this law. “It would be absurd if the planned law were now watered down because a non-transparent, technical body interferes in political decisions,” says German Green MEP Anna Cavazzini, shadow rapporteur on the Supply Chain Act in the Trade Committee. Bernd Lange also finds clear words: The RSB has become a “political assessment body” and has taken up the argumentation of Business Europe, a business association.
The body has so far been working largely in the dark. Jean-Claude Juncker set up the body in 2015. The then Commission President wanted to strengthen the then “Impact Assessment Board” and improve the quality control of legislative texts. As an independent body, the RSB is to advise the College and the Commissioners on the preparation of legislative initiatives. The Board also reviews impact assessments and evaluations for proposed legislation. It is composed of seven experts – four Commissioners and three Associate Experts.
In 2020 alone, 46 percent of impact assessments received a negative rating. The reason: “In many cases, the Commission takes too little time to adequately prepare and carry out impact assessments,” says the 2020 annual report.
If an impact assessment receives negative feedback, the Commission must improve the text and resubmit it. Two negative assessments, as in the case of the Sustainable Business Act, are extremely rare. In 2020, there was only one such case, and that was the impact assessment for a directive on equal pay for women and men. In this case, the Commission was exceptionally allowed to submit the text a third time and was given the green light.
However, the Commission can also bypass the panel in the case of two negative assessments: To do so, it needs the approval of the Deputy Commissioner for Institutional Relations and Foresight, Maroš Šefčovič – as happened with the Supply Chain Act. The law must then state the extent to which the Commission has taken the RSB’s criticisms into account. It can therefore also skip the evaluation of the RSB.
According to the statutes, the committee must act completely independently and autonomously. Members may not follow instructions from other institutions or agencies and may only meet with registered lobbyists.
So much for the theory. In practice, the composition of the committee alone is problematic. With seven members, four of them Commission officials, it is difficult to speak of an independent, autonomous body, criticizes Tiemo Wölken: “The EU officials always have the upper hand.”
In addition, the RSB has not been fully staffed for at least two years. In 2020, the board had only four members, and in some cases only three, as shown in the corresponding annual report. With only three members, the board was not able to function at all for three months.
The Commission seems to have particular difficulty in recruiting external members, who are selected on the basis of their academic performance in the field of impact assessments and regulatory policy. Even currently, only two experts are assigned to the RSB. Recruitment of a third member is “ongoing,” according to the commission. However, the search has been ongoing since the end of 2020, as can be seen from the relevant annual report.
This makes the preponderance of Commission officials even clearer. The quorum is four members, and in the event of a tie, the chair’s vote is decisive. According to the rules of procedure penned by current Chair Veronica Gaffey, formerly Director of the Commission’s Individual Claims Determination and Resolution Office (PMO), the principle of collective responsibility applies to RSB members: members may not question the decisions. However, this also means that the external members are bound by the decisions of the Commission officials. The officials could overrule the external experts on any vote.
The technical composition of the members also raises questions. According to the Commission’s decision, committee members must have expertise in macroeconomics, microeconomics, social policy and environmental policy, i.e. the three pillars of sustainable development. This is becoming increasingly relevant, especially against the background of the Fit for 55 package, even the RSB writes in its annual report.
However, if you look at the curricula vitae of the current members, only economists and financial experts sit on the committee. Only one economist with a focus on climate and environmental policy was a member until 2021: Andreas Kopp, who is now working again as a scientist at the think tank CEPS. This has also come to the attention of the EU Parliament, as can be seen from a parliamentary question by Green politician Anna Cavazzini.
The MPs also consider the transparency of the RSB to be insufficient. At a hearing of the Trade Committee, Bernd Lange spoke of a “secretive body” that was acting undemocratically. The SPD politician had tried to invite an RSB representative to the hearing to discuss the opinions on the Supply Chain Act. The panel declined. Instead, the Director-General of Commerce, Sabine Weyand, attended the meeting. But she did not answer a single question about the RSB.
The situation is similar for anyone who wants to access the panel’s assessments. For example, the Commission rejected the access-to-documents request of a researcher who had asked for opinions on the Supply Chain Act. The reason given was that these were documents relating to a decision that the Commission had not yet taken.
The Commission also rejected requests for meetings between RSB members and stakeholders on the grounds that the relevant documents did not exist. This is what happened, for example, in the case of an inquiry from Lobbycontrol about the Digital Markets Act. Only the lobbyist meetings of the RSB chairs are published.
According to the statutes, members “may not discuss individual dossiers that directly affect stakeholders,” but may only provide an overview of the body’s work. It is striking that Chairwoman Gaffey has met almost exclusively with business representatives over the past three years, most recently with the European industry association Business Europe. This does not say anything directly about the content of the discussions, but it does show that business associations have privileged access to the RSB.
However, a meeting with the French Association of Private Companies in 2020 raises eyebrows: whereas on January 17th it simply read that the association had asked for a meeting to discuss the supply chain law, ten days later the Commission added to the entry that “the chair of the RSB did not discuss the proposed law, but provided a general presentation of the body.” At the very least, this shows that the meetings are problematic in terms of maintaining the independence of the committee.
The RSB’s assessments are to be publicly available the moment the Commission publishes the corresponding legislative initiative. But to do that, you have to track down the documents first. The RSB assessment of the Digital Services Act, for example, is difficult to find. In the relevant legislative text, there is only a footnote stating, “Links to the summary and favorable opinion of the Regulatory Review Board will be included after they are published.”
Only via the register of Commission documents can the relevant decision be found. Moreover, the opinion is not complete. It refers to “technical comments” that the Board sent directly to the author of the impact assessment. These comments are not public.
Commission President Ursula von der Leyen now wants to reform the body to some extent. On March 1st, the current Director-General for Translation, Rytis Martikonis, will take over the chair from Gaffey. In the future, the committee will also examine the implementation costs of legislative initiatives and take into account strategic considerations as well as the effects of the COVID-19 pandemic.
In addition, von der Leyen would like the body to provide better information about its role in the legislative process. In this way, she wants to strengthen trust in the commission. Tiemo Wölken demands that at least the opinions be accessible immediately and not only when the laws are presented: “The current cat-and-mouse game does not help trust.”
Mr. Freytag, Mr. Duhr, parts of the digital economy are currently under enormous regulatory pressure. The effects of the General Data Protection Regulation are becoming more visible, and the supervisory authorities are more eager to make decisions.
Dirk Freytag: In principle, it is to be welcomed that the protection of consumer privacy is also enforced in accordance with the regulatory framework. We have formed many groups and working groups in our association to protect privacy and still enable business models. There must always be a balance between the two areas. However, we are in the unfortunate position that certain elements are still not there today that should actually come along with the GDPR. We, therefore, keep operating in a half vacuum. And now it is the interpretation of a legal framework that is not completely clear.
Do you mean the e-privacy regulation, which was supposed to come into force in parallel with the GDPR in 2018? You can see, for example, from the decisions of the CNIL supervisory authority in France, that this has explosive power.
Thomas Duhr: The simultaneous entry into force of the e-privacy regulation was an extraordinarily ambitious goal and actually not possible from the outset. We are currently seeing that many of the elements envisaged for this are being incorporated into numerous other legal frameworks on the part of the European Union. Parts of it can now be found in excerpts in the Digital Services Act, other parts in set pieces in the Digital Markets Act. And it is very likely that we will also find excerpts in the Data Act and Data Governance Act. In other words, we are running into a legislative structure of Babylonian proportions. With the great danger that the legal framework at the European level will end in a single prank.
That more or different regulation is necessary, I don’t think you’ll doubt.
Duhr: It is essential that the European Union sets out to further develop the digital economy with a set of rules – this is what the economy and consumers need. However, we are currently seeing an excess of activity without proper reflection and a review of the most recently introduced projects for their respective effects.
The General Data Protection Regulation, in force since 2018, has not yet been sufficiently illuminated in all its effects and facets. We would rather see such a set of rules being developed further than additions with unclear scope being herded through the village like swine. The multitude of legal acts makes it impossible for almost any market participant to even understand where they are and where they are going. This does not lead to a strengthened digital economy in the European Union. Rather, it leads to a digital Schilda.
The DSA is intended to stop some controversial practices. For example, the parliament wants to forbid the data-based targeting of minors. What do you criticize about this?
Duhr: It doesn’t belong in there. The GDPR regulates the processing of personal and personally identifiable data. With sets of rules for processing children’s data, the overall power of the GDPR is diluted. The current objective achieves exactly the opposite in real terms. How do you want to make it possible for a market participant, a website operator, to avoid violating the law? This can only be done if you distance yourself from the dictum of data minimization and data economy and a complete identification of each individual user and usage process takes place. This leads not to less data, but to more.
This would mean that I can never determine whether it is a child using the internet without having already processed his or her data. What would be the consequence?
Duhr: That every website you know today has to have a hard authentication upstream so that this website can be used at all. And I’m talking about every website, every institution, every authority, a company, a private individual. That is, I think, an internet that we can’t imagine like that.
Proponents say the regulation only targets tracking and in the end “only” the business model of tracking-based, ad-supported websites would be threatened …
Duhr: It is a misconception that tracking is a technology that is used exclusively for the issue of advertising financing. I need tracking to collect performance data, to analyze the use of my individual offering, to individualize my offering. I also need tracking technologies, correctly, to play out more specific advertising. However, it is a variety of the same technology that is needed for all other purposes in order to offer digital services on the internet.
There is a lot criticism of the business community for their attempts to persuade users to give their consent via cookie banners and “dark patterns. consent via cookie banners and dark patterns. The proposals that are now on the table aim to reduce the room for maneuver here. Has the digital economy overreached in the past?
Duhr: (Long pause) The criticism that people have exaggerated is certainly correct. As in almost all industries, there are also black sheep in the digital economy. But the reaction on the part of legislators cannot be to stipulate by law that every entry area to every department store, to every business, is absolutely identical. That is the opposite of what should actually be achieved.
You can read more about how Dirk Freytag and Thomas Duhr from the BVDW look at the DMA, the Privacy Shield debate, and the new German government on our website.
The MDR is a watershed. The requirements for market access of medical devices, for the life cycle of the product, and for notified bodies are increasing significantly. The new regulatory framework affects not only new medical devices, but also all proven and safe existing products, as well as specialty products, such as those for small patient populations. All Notified Bodies must go through a lengthy European designation process. The review time for the more extensive files is significantly increased.
The new EU regulation is already having a drastic impact on the medical technology market. BVMed conducted a survey on this in the fall of 2021, in which 88 member companies participated. More than 70 percent of BVMed member companies have already discontinued individual medical devices or entire product lines due to the new regulations brought about by the EU Medical Devices Regulation (MDR). Over 55 percent of the BVMed companies surveyed stated that previous suppliers had already discontinued their business activities due to the MDR.
Almost nine months after the MDR came into force, the medical technology industry is still ready, but the system is not. There is still a dramatic capacity bottleneck at the notified bodies. There is a threat of a huge backlog of certificates in the next few years due to scarce resources that need to be put to better use. And not only that: innovations are coming to a standstill because research departments currently have to focus on the MDR regulations.
The pressure to act is growing. Notified bodies must channel and better utilize their capacities, focus on QMS audits and reviews of technical documentation in order to clear the certification backlog. In addition, pragmatic solutions must be established for existing and niche products.
BVMed sees the following possible solutions:
Conclusion: If SMEs are forced to shift their R&D resources to regulation at the expense of innovation activity, this shows that MDR has overshot the mark. We, therefore, need to develop MDR strategically. Companies, hospitals, and physicians are all in the same boat when it comes to care and safety.
