Positions
SPECTARIS is the strong voice of high-tech small and medium-sized enterprises
Here you will find an overview of the association’s current demands and positions. SPECTARIS is committed to advocating for the legitimate interests of its members with dedication and determination.
You can find the position papers from the Consumer Optics Division here.
You can find the position papers from the Photonics Division here.
You can find the position papers from the Medical Technology Division here.
You can find the position papers from the Analysis and Laboratory Technology Department here.
SPECTARIS Scientific Report on the End of Life of Fluoropolymers in 2026
SPECTARIS on the Ongoing PFAS Restriction Process in the EU
SPECTARIS on the ongoing PFAS restriction process in the EU
SPECTARIS Recommendations for the 21st German Bundestag and the New Federal Government
Joint Statement by the German Medical Device and In Vitro Diagnostics Associations on the Medical Research Act
SPECTARIS Recommendations for the 2024 European Elections
SPECTARIS' Position on Investments by EU Companies in Non-EU Countries
Position Paper on the Proposal for a Universal Restriction on PFAS in Europe
SPECTARIS' Position on the Proposed PFAS Restrictions in Europe
Electronic Instructions for Use (eIFU) for Medical Devices
Electronic Instructions for Use (eIFU) for Medical Devices
Statement on "Circumvention of Sanctions Against Russia"
SPECTARIS's Position on the Blanket Ban on Per- and Polyfluoroalkyl Substances (PFAS)
SPECTARIS' Position on the Blanket Ban on Per- and Polyfluoroalkyl Substances (PFAS)
Position Paper on the Cyber Resilience Act
As part of the “Industrial Strategy Workshop Discussions” organized by the Federal Ministry for Economic Affairs and Cooperation (BMWK), SPECTARIS was asked to present the most important recommendations from our industries. This brief statement focuses on four key points that are relevant across all four SPECTARIS industries and are also appropriately addressed by the BMWK: • Expand and accelerate R&D funding for key technologies • Strengthen foreign trade • Define and implement a framework for technological sovereignty • Promote skilled immigration to combat the shortage of skilled workers
Input on the Development of an Industrial Strategy by the BMWK
SPECTARIS Statement on the Draft Regulation—Special Fees Regulation
Key Points for a Proposed Arms Export Control Act
Emergency Program to Safeguard the Survival and Future of Key Industries and the Healthcare Sector in Germany
Position Paper on China: China and the German Optics, Photonics, Analytical, and Medical Technology Industries, and Analysis of the Member Survey
These two documents are available only to logged-in members.
Proposal for a Directive of the European Parliament and of the Council on Corporate Sustainability Due Diligence
Effectively banning products produced, extracted, or harvested using forced labor
Draft Act on the Comprehensive Economic and Trade Agreement (CETA) between Canada, on the one hand, and the European Union and its Member States, on the other hand, dated October 30, 2022
SPECTARIS Statement on the Draft Bill for Better Protection of Whistleblowers and on the Implementation of the Directive on the Protection of Persons Reporting Violations of Union Law (RefEnt-HiSchG)
The industry association SPECTARIS supports and welcomes this draft bill on the Whistleblower Protection Act (RefEnt-HiSchG) and its underlying intent, namely to protect whistleblowers without imposing a disproportionate burden on companies.
SPECTARIS Statement on the Draft Amendment to the Higher Education Act (RefEnt-HiSchG)
Recommendations for the 20th Legislative Session
The 20th legislative period will be decisive for the economic future of the optics, photonics, analytical, and medical technology sectors. As part of the coalition negotiations, the SPD, the Greens, and the FDP formed 22 working groups. Within these groups, policy experts from the three parties negotiated the details of the coalition agreement on various issues and policy areas. The German industry association SPECTARIS has written to the working groups relevant to its sectors and formulated recommendations that should be taken into account in a coalition agreement. You can read the recommendations for the individual working groups here:
- Economy
- Health and Care
- Innovation, Science, and Research
- Security, Defense, Development, Foreign Affairs, Human Rights
- Digital Innovations and Digital Infrastructure
- Europe
- Finance and Budget
Position Paper: SPECTARIS Guidelines for a New Direction in Economic Policy
Germany’s framework conditions must climb back to the top of the international business location rankings from their current mid-table position. In this way, the high-tech companies of the German industry association SPECTARIS can make a tangible contribution to the post-COVID economic recovery. SPECTARIS therefore calls on policymakers to take the following guidelines for economic policy into account during the new legislative terms of the federal and state governments.
Statement on EU-U.S. Cooperation on Export Controls within the Framework of the EU-U.S. Trade and Technology Council (TTC)
The statement can be read here.
SPECTARIS Statement on the Draft Bill for the Seventeenth Amendment to the Foreign Trade and Payments Ordinance
SPECTARIS Comments on the Drafts of an AI Regulation and a Machinery Regulation
In early August 2021, the deadlines for participating in the European Commission’s consultations on the proposed drafts of a regulation on artificial intelligence (AI Regulation) and a regulation revising the Machinery Directive (Machinery Regulation) expired. SPECTARIS participated in both consultations.
European Union Blocking Regulation
To protect European companies that have invested in Iran and entered into long-term supply contracts, the Commission took several steps on May 18, 2018. Among these measures is the initiation of a formal procedure to activate the so-called “Blocking Regulation” (Regulation (EC) No. 2271/96) to provide protection against the effects of the extraterritorial application of legal acts adopted by a third country, as well as measures based on or resulting from such acts.
Nevertheless, the “blocking regulation” represents a lose-lose situation for many SPECTARIS members, as they are now faced with two conflicting legal provisions and may have to establish two separate compliance frameworks, the adherence to which entails additional costs.
As of October 2021
SPECTARIS Position Statement
Strengthening Key Industries in the Wake of the Pandemic
The SPECTARIS industries have so far been harder hit by the COVID-19 crisis than generally assumed. With expected revenue declines of up to 20% in 2020 compared to the previous year, member companies assessed the situation in April as very pessimistic on average, since even in the German medical and laboratory technology sectors, only a few companies could anticipate stable or even rising revenues. A program that sustainably strengthens SPECTARIS’s high-tech sectors is therefore of central importance. With its catalog of proposals titled“Strengthening Key Industries After COVID-19: A Forward-Looking Program for German Optics, Photonics, Analytical, and Medical Technology,” SPECTARIS is now engaging in discussions with policymakers and can build on the current plans of the Federal Ministry for Economic Affairs and Energy.
SPECTARIS Statement on the Draft MPDG Amendment Act
Addition to § 72, new paragraph 6
(6) Products owned by the patient may be transferred to the manufacturer or to the competent federal supervisory authority for examination purposes as part of the risk assessment under paragraph 2 only with the patient’s prior consent or, if the patient is unable to give informed consent, with the consent of the patient’s legal or contractual representative. The first sentence applies mutatis mutandis to an examination in which destruction of the product is unavoidable; the patient must be informed of the risk of destruction of the product before giving consent pursuant to the first sentence. Prior to any unavoidable destructive examinations, the manufacturers, the competent federal supervisory authority, or the experts commissioned by it shall prepare photographic documentation of the product to be examined. This photographic documentation, as well as a copy of the examination report, shall be provided to the affected patient or his or her legal or authorized representative upon request.
’s Assessment: In principle, the addition to paragraph 6 of § 72 is reasonable. From the manufacturers’ perspective as well, it is necessary and sensible to obtain the patient’s prior consent before conducting (destructive) tests on products owned by the patient. To avoid legal uncertainty, however, we suggest two clarifications to the text of the law.
The proposed addition to Section 72(6) refers to “products owned by the patient.” As paragraph V clarifies, these are products and sample materials suspected of being involved in a serious incident. In the explanatory memorandum (p. 21, last paragraph; p. 26), the legislature therefore correctly refers to implants as well. To ensure legal certainty in this regard, we therefore suggest that this clarification be included in the text of the law as well.
In the explanatory memorandum (p. 21), the legislature correctly states that healthcare facilities must obtain informed consent. To avoid legal uncertainty regarding responsibilities, we suggest that this be clarified in the text of the law as well.
Proposed amendments:
(6) Implants that are the property of the patient may be transferred to the manufacturer or the competent federal supervisory authority for examination purposes as part of the risk assessment under paragraph 2 only with the prior informed consent of the patient or, if the patient is unable to give informed consent, of the patient’s legal or contractual representative. Healthcare facilities are responsible for providing the patient with information and obtaining the patient’s consent.
Proposed amendments:
(6) Implants that are the property of the patient may be transferred to the manufacturer or to the competent federal supervisory authority for examination purposes as part of the risk assessment under paragraph 2 only with the prior informed consent of the patient or, if the patient is unable to provide informed consent, of the patient’s legal or authorized representative. Healthcare facilities are responsible for providing the patient with information and obtaining the patient’s consent.
6 Demands from High-Tech Small and Medium-Sized Enterprises
Small and medium-sized, export-oriented, and innovative— these are the hallmarks of the medical technology, photonics, ophthalmic optics, and analytical, biotechnology, and laboratory technology sectors represented by the industry association SPECTARIS. The majority of the approximately 300,000 employees work for small and medium-sized enterprises with fewer than 250 employees. Overall, these sectors generate over 60 percent of their total annual revenue—just under 70 billion euros—on a global scale, making them particularly strong in exports. At the same time, these sectors are exceptionally innovative: for example, German medical technology ranks second worldwide in the number of patents filed, behind the global market leader, the United States.
SPECTARIS calls on policymakers to support the backbone of the German economy. After all, strengthening small and medium-sized businesses drives innovation and ensures Germany’s future as a business hub.
Future Partnership Between the European Union and the United Kingdom – Requirements from the SPECTARIS Industries
On January 31, 2020, Brexit became a reality. As of February 1, 2020, the United Kingdom is no longer a member of the European Union (EU). Initially, a transition period will remain in effect until at least the end of 2020, during which EU law and the case law of the European Court of Justice will continue to be binding on the United Kingdom.
The goal is to negotiate the future relationship with the European Union during the 11-month transition period—an ambitious goal, especially since the outbreak of the COVID-19 pandemic in Europe. While there is technically the possibility of extending the transition period by another two years by mutual agreement, the British side has already clearly rejected such an extension on multiple occasions. This means that a “hard Brexit 2.0” remains a possibility.
Making Tax Incentives for Research Attractive to SMEs
Spectaris Position Paper on Safeguarding Germany as a High-Tech Hub
We have prepared a position paper for the future federal government in which we address the issues that are important to our innovative high-tech SMEs: digitalization, innovation research, overregulation, and free trade.
As of January 12, 2018
SPECTARIS Position Paper
The United States' Withdrawal from the Joint Comprehensive Plan of Action
On May 8, 2018, U.S. President Donald Trump announced that the United States of America (USA) was withdrawing from the Joint Comprehensive Plan of Action (JCPOA). Following a transition period of 90 or 180 days, the U.S. sanctions against Iran that had been suspended under the JCPOA came back into full effect.
One goal of the U.S. sanctions is to isolate Iran from the global financial market. Nearly all German and European banks have suspended payment transactions with Iran so as not to jeopardize their access to the U.S. financial market. The banks’ withdrawal from business with Iran is particularly bitter for German medical technology companies, since they could continue to supply Iran without violating U.S. sanctions. This is because, under an exemption granted by the U.S. Office of Foreign Assets Control (OFAC), both U.S. and non-U.S. companies are still permitted to supply certain medical devices and humanitarian goods to Iran.
As of November 2018
The Importance of Per- and Polyfluoroalkyl Substances (PFAS) for High-Tech Industries
The REACH authorities in Germany, the Netherlands, Norway, Sweden, and Denmark plan to draft a REACH restriction proposal aimed at restricting the manufacture, placing on the market, and use of all per- and polyfluoroalkyl substances (PFAS) in the EU. The countries’ main concern is the very high persistence of these chemicals in the environment and the potential contamination of groundwater, surface water, and drinking water.
However, a ban on all PFAS substances would have dramatic consequences for the supply of medical and laboratory equipment to healthcare systems, as well as for digitalization, where these substances are indispensable. Currently, there are more than 4,700 different PFAS substances on the market, and new PFAS are continually being developed. From SPECTARIS’s perspective, it is therefore important to take a differentiated approach to PFAS substance groups and not to impose a blanket restriction on all PFAS substances.
Germany Needs a National eHealth Vision
To ensure the successful digitization of healthcare in Germany, the medical technology, biotechnology, health IT, and pharmaceutical industries—as the central cornerstones of the industrial healthcare sector—are jointly calling for the development of a national eHealth vision and the implementation of an eHealth strategy derived from it.
As of January 25, 2018
SPECTARIS Statement
U.S. Sanctions Legislation: Countering America's Adversaries Through Sanctions Act (CAATSA)
In August 2017, U.S. President Donald Trump signed a law to implement and expand sanctions, known as the “Countering America’s Adversaries Act” (CAATSA). The law tightens U.S. sanctions against Iran, Russia, and North Korea. Attached you will find SPECTARIS’s statement on CAATSA. This legislation is of extraordinary importance to many SPECTARIS member companies, as Russia in particular is a key export market and the law also applies to German companies that conduct business with designated individuals or their relatives.
As of November 2017
SPECTARIS Statement
SPECTARIS' Key Policy Positions: The Top 15
The German industry association SPECTARIS represents the interests of 400 predominantly small- and medium-sized high-tech companies in the consumer optics, photonics, medical technology, and analytical, biotechnology, and laboratory technology sectors. All of these companies are characterized by their strong innovative capacity and significant export business. The following proposals and recommendations for improving the political and legal framework are central to the economic success of these industries.
Harnessing Germany's Strength in Photonics for Industry 4.0: Policy Recommendations
Germany is currently one of the world’s leading countries in the development and manufacture of optical system solutions. Through the Photonics 4.0 Alliance, the initiators—SPECTARIS and WLT—not only highlight the potential of photonics in the production of the future, but also present concrete proposals for policy action.
As of May 2017
SPECTARIS Statement (German)
Impact of the Implementation of U.S. Section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (FY19 NDAA) on U.S. Procurement Policy and German Companies Participating in It
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What Our Members Say
SPECTARIS acts as a strong association that vigorously represents the interests of its members in the political, business, and social spheres.
“SPECTARIS acts as a strong association that vigorously represents its members’ interests in the political, business, and social spheres. As members, we have the opportunity to actively raise our concerns and help shape the agenda to ensure that our voice is heard in relevant political and social discussions. In addition, through SPECTARIS, we have access to a broad network of companies, experts, and decision-makers from the high-tech industry. This allows us to forge valuable contacts and leverage synergies. Through this exchange, we and other members can benefit from each other’s experiences and expertise.”
Frank-Martin Rammelt, Managing Director of seleon GmbH
Together, we are strong.
Together we are strong—That is why we value the strong network and the open and excellent collaboration within the association, which allows us, as one of the leading manufacturers, to work together on solutions to the modern challenges in the contact lens industry, to collaborate on joint campaigns, and to capitalize on identified trends.
Johannes Zupfer, General Manager for Germany, Austria, and Switzerland, CooperVision GmbH
Advancing Photonics
Photonics is one of the most innovative key industries and places high demands on the organizations that represent its interests. SPECTARIS meets these demands in a compelling manner. As a strong industry association, SPECTARIS effectively represents the interests of its members in the political, business, and social spheres, while also promoting exchange and networking within the industry. We thank SPECTARIS for this commitment and greatly value our trusting collaboration.
Dr. Ralf Kuschnereit, JENOPTIK AG
OBE relies on high-quality products “Made in Germany.”
OBE relies on high-quality products “Made in Germany.” Thanks to innovation and automation, spring hinges and security screws can be manufactured in large quantities at the Ispringen facility. This goes hand in hand with increased productivity and a division of labor for simple products at our facility in China. In this way, we secure jobs in Germany.
Peter Specht / Erik Schäfer - Managing Directors, OBE
Community makes us strong!
For us as medium-sized companies, the SPECTARIS association serves as a bridge between the government and our interests—our collective strength makes us stronger! We appreciate the very helpful continuing education program in the field of medical technology and benefit from the organization of a wide variety of delegation trips. Our membership in SPECTARIS also ensures that we receive regular updates on new regulatory requirements.
Maik Greiser, Managing Partner / CEO, ATMOS MedizinTechnik GmbH & Co. KG
The association offers services that are perfectly tailored to our needs.
Our industry association, SPECTARIS, is a strong advocate for the interests of medium-sized, owner-managed companies like ours. It is just as important to us that the association provides a platform for open dialogue among member companies and offers services—such as industry reports and events focused on specific topics—that are perfectly tailored to our needs.
Managing Partners of Jüke Systemtechnik GmbH, Martin Hovestadt (left) and Heinrich Jürgens (right)
A Voice for Medical Technology
For us as a medical technology manufacturer, SPECTARIS serves as an important voice in our dealings with policymakers. Especially in light of the current MDR, it is immensely important to have a strong and effective association to represent our interests. We are very satisfied with our collaboration and feel well represented.
Regina Kirchner-Gottschalk, Managing Director of KaWe – KIRCHNER & WILHELM GmbH + Co. KG
Innovation drives us forward
Demands are growing, markets are changing—but innovation opens up new paths for us. With digital progress, bold ideas, and modern processes, we are shaping the standards of tomorrow. As a SPECTARIS member, we leverage the strength of the network to actively shape the future in this dynamic environment.
Fabian Bohnen, COO / Stephan Börner, CEO, Ofa Bamberg GmbH
What we particularly appreciate about SPECTARIS is its technical expertise.
As a medium-sized medical technology company, Richard Wolf benefits greatly from SPECTARIS’s extensive network. We particularly value their technical expertise.
Management of Richard Wolf GmbH: Mr. Pfab, Mr. Steinbeck
It's worth getting involved!
In times of rapid and far-reaching changes in the medtech industry and a challenging regulatory environment, SPECTARIS is an important partner for our company and plays an indispensable role as an advocate for our interests in Berlin and Brussels. It’s worth getting involved!
Bert Sutter, Managing Director, Sutter Medizintechnik GmbH
We want to be a trusted partner for our laboratory customers, both today and in the future.
SPECTARIS’s in-depth information on industry and technology trends, as well as the regulatory landscape, is just as important to us as its advocacy work in Berlin and Brussels. The dedicated SPECTARIS team is always a great point of contact for us.
Dr. Christoph Schöler, Managing Partner, BRAND GMBH + CO KG, VACUUBRAND GMBH + CO KG
A voice for the industry
In a diverse and specialized industry such as analytical technology—which is highly technical and subject to numerous regulatory requirements—small specialists compete with large technology conglomerates. SPECTARIS succeeds in uniting the interests of all its members and serves as the industry’s collective voice and advocate.
Albrecht Sieper, Managing Director of Elementar Analysensysteme GmbH
SPECTARIS is the ideal platform.
SPECTARIS provides us with the ideal platform for constructive dialogue with member companies and serves as a reliable voice for the laboratory industry in the realms of politics and science.
Dr. Gunther Wobser, Managing Partner of LAUDA DR. R. WOBSER GMBH & CO. KG
SPECTARIS fosters collaboration in our industry.
“The very informative discussions at SPECTARIS in Berlin and here at our office convinced me of SPECTARIS’s commitment and the quality of its work. In particular, the opportunity to combine topics from analytical, biotechnology, and laboratory technology with the field of medical technology is very interesting for Sigma,” I wrote upon joining in 2011. This has been confirmed, and today we are actively involved in several working groups.
Dr. Michael Sander, Managing Director of Sigma Laborzentrifugen GmbH
National advocacy group puts the spotlight on the industry
Laser Components benefits from the industry association in a variety of ways. As a company, we value the broad exchange of information within the working groups—whether in human resources, marketing, or export control, customs, and foreign trade practices. For our industry, Spectaris also serves as a political voice—the Photonics Trade Association not only maintains constant communication with the BMWi and BMBF ministries but also provides information on European initiatives.
Patrick Paul, Managing Director of LASER COMPONENTS GmbH
A Voice for Innovative Small and Medium-Sized Businesses
In the century of the photon, we need an advocacy group that is both strong and responsive. For us, as providers and consultants for the most innovative products on the global photonics market, this institution is particularly important. We know our interests (e.g., in the area of foreign trade) are in good hands, and we can focus on what matters most: satisfying our customers.
Andreas Börner, Managing Director of Laser 2000 GmbH
Our membership in the SPECTARIS industry association is of great value to us.
It not only gives us access to a strong network of leading companies across various high-tech industries, but also provides an important platform for professional exchange and continuing education. In addition, we benefit from the association’s strong advocacy with policymakers, the business community, and society at large, which plays a crucial role in creating a sustainable framework for the future. Through our membership in SPECTARIS, we can contribute our expertise, address current developments at an early stage, and jointly drive innovation and sustainable growth.
Frank Billhardt, Laser Protection Division EMEA, LASERVISION GmbH & Co. KG
