Positions

An Overview of Our Positions

SPECTARIS addresses various aspects of health policy—whenever the interests of the medical technology industry are at stake. One of the central tasks of the Medical Technology Trade Association is therefore to represent the medical technology industry in dealings with policymakers and the public. In the highly regulated field of health policy, the association not only has reliable connections to Berlin’s political circles but is also well-connected through its membership in the European medical technology umbrella organization MedTech Europe in Brussels. 

SPECTARIS not only responds to changes in the legal landscape or current inquiries, but also actively addresses issues. The association creates opportunities for business representatives to engage in personal dialogue with policymakers and works with its members to develop constructive solutions.

2024

July 2024

SPECTARIS Draft Proposal dated July 30, 2024, for the Incorporation of an Index-Based Cost Equalization Mechanism into SGB V, Supplementing Point 1 of the Position Paper “Medical Aid Reform: What Must Happen Now!” dated January 11, 2024

Updated SPECTARIS Position Paper dated July 30, 2024: "Ensuring Quality of Care and Local Access to Assistive Devices Through Standardized, Universally Applicable Framework Agreements"

June 2024

SPECTARIS Statement
on the occasion of the Health Committee hearing on the motion by the CDU/CSU parliamentary group—“Ensuring the Supply of Medical Devices—Sustainably Strengthening the Healthcare Industry”

May 2024

Joint Statement by the German Medical Device and In Vitro Diagnostics Associations
Regarding the Cabinet Decision by the Federal Ministry of Health and the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety, and Consumer Protection on a Medical Research Act

April 2024

SPECTARIS Statement on the Draft Bill to Strengthen Health Care in Municipalities (Health Care Strengthening Act—GVSG)

SPECTARIS Statement on the Federal Ministry of Health’s Draft Bill for a Law to Improve the Quality of Hospital Care and Reform Payment Structures (Hospital Care Improvement Act – KHVVG)

February 2024

SPECTARIS Statement on the Draft Bill by the Federal Ministry of Health and the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety, and Consumer Protection: “Draft Medical Research Act (MFG)”

Joint Position Paper by the Medical Technology Industry Associations in Germany on the Further Development of the MDR and IVDR

SPECTARIS Position Paper on the Proposed PFAS Restrictions in Europe
White Paper: “Telemedicine in Emergency Medical Services: Setting the Course for a Digital Future”

January 2024

Reform of Assistive Devices: This Is What Needs to Happen Now!

2020

December 2020

SPECTARIS Statement on the Draft Bill for a Law on the Digital Modernization of Healthcare and Long-Term Care (Digital Healthcare and Long-Term Care Modernization Act – DVPMG)

November 2020

Position Paper on Health and Economic Policy in the Medical Technology Sector by the German Industry Association SPECTARIS for the 2021 Federal Election (Long Version)

Position Paper on Health and Economic Policy in the Medical Technology Sector by the German Industry Association SPECTARIS for the 2021 Federal Election (Short Version)

August 2020

Joint Statement on the Substantive Structure of the DiGA Care Process

SPECTARIS Statement on the Draft Bill to Improve Health Care and Long-Term Care (Health Care Improvement Act – GPVG)

SPECTARIS Statement on the Draft Bill for a Future Program for Hospitals (Hospital Future Act – KHZG)

June 2020

Supplement to the IGHV Inquiry: BVMed and SPECTARIS: Implementation of the VAT Reduction Effective July 1, 2020, in the Supply of Medical Devices, dated June 30, 2020

Supplementary inquiry from the IGHV to the GKV-Spitzenverband dated June 26, 2020, regarding uniform implementation in the context of medical aid provision and billing: Value-Added Tax (VAT) change from July 1, 2020, through December 31, 2020

Request from the IGHV to the GKV-Spitzenverband dated June 15, 2020, regarding uniform implementation in the context of medical aid provision and billing: Value-Added Tax (VAT) change from July 1, 2020, through December 31, 2020

SPECTARIS Statement on the Draft Regulation on the Procedural Principles for the Evaluation of Diagnostic and Treatment Methods in Contract-Based Medical Care and in Hospitals (Regulation on Method Evaluation Procedures—MBVerfV)

May 2020

IGHV Position Paper on Telematics Infrastructure: Assistive Device Providers in the Healthcare Network

Integrate Information on Assistive Devices into Electronic Health Records

Position Paper by the Interest Group for Assistive Technology Provision (IGHV)

Requirements for Ensuring the Supply of Medical Devices | During and After COVID-19

April 2020

SPECTARIS Statement on the Draft Regulation on the Procurement of Medical Devices and Personal Protective Equipment in Response to the Epidemic Caused by the SARS-CoV-2 Coronavirus, dated April 7, 2020

SPECTARIS Statement on the Draft Regulation on the Adaptation of Medical Device Law to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MPEUAnpV)

March 2020

IGHV Paper on the SARS-CoV-2 Coronavirus | Relieving the Burden on Hospitals Through Safe Outpatient Care with Medical Devices

SPECTARIS Information on Administrative Relief Measures Related to the COVID-19 Crisis: Ensuring the Supply of Systemically Important Respiratory Equipment

February 2020

SPECTARIS Statement on the Draft Law on the Protection of Electronic Patient Data in the Telematics Infrastructure (Patient Data Protection Act – PDSG)

SPECTARIS Statement on the Regulation on the Procedure and Requirements for Assessing the Reimbursability of Digital Health Applications under Statutory Health Insurance (Digital Health Applications Regulation – DiGAV)

January 2020

Part I of the SPECTARIS Statement on the Draft Act to Align Medical Device Law with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – (Medical Devices EU Alignment Act – MPEUAnpG)

Part II of the SPECTARIS Statement on Amendment 3 proposed by the CDU/CSU and SPD parliamentary groups to the draft law on the alignment of medical device law with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (EU Medical Devices Alignment Act – MPEUAnpG)

2019

October 2019

SPECTARIS Information on the Impact of the Medical Device Regulation (MDR)

SPECTARIS Statement on the Federal Government’s Draft Bill for Improved Healthcare Through Digitalization and Innovation (Digital Healthcare Act – DVG)

September 2019

SPECTARIS Statement on the Draft Bill for a Medical Devices Amendment Act (MPAnpG)

SPECTARIS Statement on the Draft Bill to Strengthen Rehabilitation and Intensive Care in Statutory Health Insurance (Rehabilitation and Intensive Care Strengthening Act – RISG) dated August 15, 2019

August 2019

SPECTARIS' Position on Guidelines for Regulation-Compliant Hygienic Reprocessing as a Key Factor in Protecting Patients, Staff, and Equipment

June 2019

SPECTARIS Statement on the Federal Government’s Draft Bill to Establish the German Implant Registry and to Make Further Amendments to Book Five of the Social Code (Implant Registry Establishment Act—EIRD) dated June 17, 2019

SPECTARIS Statement on the Draft Bill for Improved Healthcare Through Digitalization and Innovation (Digital Healthcare Act – DVG) dated May 15, 2019

SPECTARIS Statement on the Draft Bill to Establish the German Implant Registry and on Further Amendments to Book Five of the Social Code (Implant Registry Establishment Act – EIRD)

May 2019

The Timeline for the New European Medical Device Regulation Puts Patient Care at Risk and Slows Innovation

Position Paper on Electronic Instructions for Use: Implementing Act on Electronic Instructions for Use (in English) 

Perspective on Assistive Device Provision: Improving Quality Through Contractual Agreements and Performance Monitoring. Greater Input for Manufacturers and Service Providers.

March 2019

Discussion Paper: Modernizing Structures. Clarifying Responsibilities. Shaping Digitalization Together.

February 2019

SPECTARIS Statement
A) on the draft bill for a law establishing a German Implant Registry (Implant Registry Establishment Act – EDIR) dated January 28, 2019
and
B) on the amendments to the EDIR draft bill dated February 20, 2019 (Acceleration of the Evaluation of Diagnostic and Treatment Methods)

SPECTARIS Statement
on Amendment 28 (new) of January 24, 2019 (Accelerating the Evaluation of Diagnostic and Treatment Methods)
regarding the draft law for faster appointments and better care (Appointment Service and Care Act – TSVG)

SPECTARIS Statement
on Amendment 2 of January 24, 2019 (Prohibition of Bidding Processes and Open-House Contracts in the Provision of Medical Devices) to the Draft Act for Faster Appointments and Better Care (Appointment Service and Care Act—TSVG)

Discussion Paper: “Access to Standard Care Through Digital Healthcare Services”

2018

December 2018

Statement by the Associations on the European Commission’s January 2018 Proposal for an EU HTA Regulation (“Health Technology Assessment”)

SPECTARIS Information Paper for Payers and Non-Medical Service Providers in Respiratory Home Therapy:
Classification of Sleep Apnea Respiratory Therapy Devices as Medical Devices Under Annex 1 of the MPBetreibV and the Possible Consequences

November 2018

Implications of the New EU Medical Device Regulation (MDR) for Patients and the Industry

Call to Action: Ensuring the Usability of Electronic Health Records for Research and Care

June 2018

SPECTARIS Position Paper on eHealth: Connectivity for Greater Efficiency and Quality in Health Care 

May 2018
Position Paper on Strengthening the Federal Insurance Office and State Supervisory Authorities in Legal Oversight Proceedings Concerning Health Insurance Plans’ Provision of Medical Aids

Position Paper on the Appropriateness of Solicitations for the Procurement of Ventilators for Use in the Home Setting

 Accelerating the Processes for Evaluating Innovative Medical Technology

Position Paper on Accelerating the Procedures for Evaluating Innovative Medical Devices

February 2018
Position Paper on the Benefits of a Standard-Compliant, Modern, and High-Quality Nursing Bed for the Patient and for a Cost-Effective Healthcare System 
December 2018

Statement by the Associations on the European Commission’s January 2018 Proposal for an EU HTA Regulation (“Health Technology Assessment”)

SPECTARIS Information Paper for Payers and Non-Medical Service Providers in Respiratory Home Therapy:
Classification of Sleep Apnea Respiratory Therapy Devices as Medical Devices Under Annex 1 of the MPBetreibV and the Possible Consequences

November 2018

Implications of the New EU Medical Device Regulation (MDR) for Patients and the Industry

Call to Action: Ensuring the Usability of Electronic Health Records for Research and Care

June 2018

SPECTARIS Position Paper on eHealth: Connectivity for Greater Efficiency and Quality in Health Care 

May 2018
Position Paper on Strengthening the Federal Insurance Office and State Supervisory Authorities in Legal Oversight Proceedings Concerning Health Insurance Plans’ Provision of Medical Aids

Position Paper on the Appropriateness of Solicitations for the Procurement of Ventilators for Use in the Home Setting

Accelerating the Processes for Evaluating Innovative Medical Technology

Position Paper on Accelerating the Procedures for Evaluating Innovative Medical Devices

February 2018
Position Paper on the Benefits of a Standard-Compliant, Modern, and High-Quality Nursing Bed for the Patient and for a Cost-Effective Healthcare System 

< 2018

2017

September 2017

Position Paper by the Interest Group for Assistive Device Provision (IGHV) on the Inadmissibility of Open-House Procedures in the Assistive Device Sector

Cost-Effectiveness of Services and Medical Devices: A Case Study on the Care of Ventilator-Dependent Patients (August 2017)

Position Paper on the Necessary Requirements and Care Steps for Healthcare Providers in the Care of Patients Who Require Ventilation

June 2017
Position paper on the benefits of a standards-compliant, modern, and high-quality nursing bed for the patient and for a cost-effective healthcare system
May 2017
Positions of the German Medical Technology Association on the 2017 federal election
Position paper on the Medical Device Operator Regulation (MPBetreibV)

2016

November 2016
SPECTARIS Statement on the Draft Bill to Strengthen the Supply of Medical Devices and Assistive Devices (HHVG)
September 2016
Press release from the Interest Group for Medical Aids Supply (IGHV) on the Cabinet’s draft of the Medical Aids and Therapeutic Devices Supply Act (HHVG)
July 2016
Statement on the Draft Bill to Strengthen the Provision of Medical Devices and Assistive Devices (HHVG)
 
March 2016
Position Paper on the Key Points Paper “Further Development of the Quality of Assistive Device Provision”
Position Paper on the Image and Situation of Inpatient Care
 
January 2016
Statement on the Draft Bill for a Fourth Act Amending Pharmaceutical and Other Regulations dated November 25, 2015

2015

November 2015

Statement on the Government’s Draft Bill to Combat Corruption in the Healthcare Sector (Bundestag Document 18/6446)
Statement on the Draft Regulation on the Requirements for the Evaluation of New Diagnostic and Treatment Methods Using High-Risk Medical Devices Pursuant to Section 137h of Book V of the Social Code (Social Code Book V) (Medical Device Method Evaluation Regulation – MeM-BV)

October 2015
Statement on the Act on Secure Digital Communication and Applications in Healthcare—the eHealth Act
May 2015
Brief Statement Supplementing the SPECTARIS Statement of February 10, 2015 


Supplement to the Draft Bill on Secure Digital Communication and Applications in Healthcare (eHealth Act)

April 2015
Statement on the Draft Bill to Combat Corruption in the Healthcare Sector
 
March 2015
Statement on the Draft Bill to Strengthen Care in the Statutory Health Insurance System (GKV Care Strengthening Act – GKV-VSG)
Position Paper on the Provision of “Long-Term Oxygen Therapy” to Patients Without a Physician’s Prescription
Supplement to the Position Paper by the Interest Group for Medical Aid Provision (IGHV) on Tenders in the Medical Aid Sector dated January 13, 2015
Joint Position Paper by the Interest Group for Medical Aid Provision (IGHV) on Tenders in the Medical Aid Sector 

2011

April 2011

Framework Conditions for Innovation in Medical Technology Care: Benefit Assessment, CE Marking, Reimbursement

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

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


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


The medical technology industry is a highly diverse, dynamic, and innovative sector

The medical technology industry is a highly diverse, dynamic, and innovative sector that must adapt to constantly changing conditions. It faces significant pressure due, among other factors, to technological, regulatory, economic, and geopolitical shifts. As a medium-sized company, we are confident that, with SPECTARIS, we have a powerful industry association at our side that effectively represents our interests in the political arena and the public sphere, while also helping us successfully meet the challenges ahead through its expertise and an outstanding network of experts.


Monica Waskönig, CEO of Temena GmbH


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