Regulatory Affairs

Regulatory Affairs Forum for Analytical, Biotechnology, and Laboratory Technology
The Regulatory Affairs Forum for Analytical, Biotechnology, and Laboratory Technology (RF ABL) provides an overview of national, European, and international regulatory requirements for products in the fields of analytical, biotechnology, and laboratory technology. Current developments and issues are explored in depth through presentations and discussed in group sessions. Between meetings, members regularly receive up-to-date information on regulatory developments in the fields of analytical, bio-, and laboratory technology, as well as the opportunity to submit comments on legislative measures and current issues that serve their interests.

Medical Technology Regulatory Affairs Forum
Twice a year, regulatory affairs experts from member companies meet as part of the Medical Technology Regulatory Affairs Forum. At these meetings, they receive updates on and discuss current topics such as the new Medical Device Regulation, as well as other issues related to national and international medical device legislation. Topics deemed particularly important by the members are explored in greater depth during the meetings with external speakers. Between meetings, members regularly receive up-to-date information on regulatory developments in the medical technology sector and have the opportunity to provide input on specific legislative measures and current issues.

Photonics Regulatory Affairs Forum
The Photonics Regulatory Affairs Forum provides an overview of national, European, and international regulatory requirements for products incorporating photonic technologies. Key topics deemed particularly important by the members are explored in greater depth during meetings with external experts and discussed within the group. Between meetings, members regularly receive up-to-date information on regulatory developments in the field of photonics and have the opportunity to provide input on specific legislative measures and current issues.

Cybersecurity Working Group Ensuring the security of information and communication technology is of particular importance to SPECTARIS members who manufacture network-enabled devices and software. Cyberattacks—for example, on healthcare facilities with networked medical devices—are no longer mere future scenarios but are already acute threats. To implement an appropriate level of state-of-the-art cybersecurity, the working group aims to develop a common understanding of cybersecurity and facilitate a dialogue on current technical and regulatory challenges.

Working Group on Fluorinated Greenhouse Gases
Regulation (EU) No. 517/2014 on fluorinated greenhouse gases has been in effect since January 1, 2015, and it severely restricts the use of fluorinated greenhouse gases as refrigerants. Within the SPECTARIS Trade Association for Analytical, Bio-, and Laboratory Technology, this affects manufacturers of refrigerated centrifuges, thermostats, and laboratory freeze dryers. The Fluorinated Greenhouse Gases Working Group supports the implementation of the regulation through the exchange of experiences, information gathering, and political advocacy.  

International Market Access Working Group
Within the International Market Access Working Group, SPECTARIS members discuss a wide range of market access conditions for medical devices on the global market. The group has its roots in the ASEAN Project Group, which had primarily focused on the ASEAN economic region. As it became clear over time that this regulatory exchange was also necessary with regard to other international markets, the International Market Access Working Group now addresses regulatory challenges worldwide.

In Vitro Diagnostics (IVD) Working Group
With the entry into force of EU Regulation 2017/746/EU on in vitro diagnostics (IVDR), the framework conditions for placing in vitro diagnostic medical devices (IVDs) and their accessories on the market are changing. The IVD Working Group monitors and assists with current developments at the European and national levels regarding the implementation of the EU Regulation. The goal is to foster a common understanding among participants regarding the requirements to be implemented and to discuss potential solutions to emerging issues.

MDR Working Group
With the entry into force of EU Regulation 2017/745/EU on medical devices (Medical Device Regulation—MDR), the framework conditions for placing medical devices and their accessories on the market are changing. The MDR Working Group monitors and actively contributes to current developments at the European and national levels regarding the implementation of the EU Regulation. Thanks to the active participation of some MDR Working Group members in various working groups at the European level, there is a regular exchange of information. Specific issues related to the MDR are discussed and addressed in depth by separate task forces.

MDR / UDI Optometry (Class I) Working Group
The goal of the working group is to collaboratively address the challenges posed by the Medical Device Regulation (MDR) for Class I optometry products. To find practical solutions for implementing the MDR in the optical industry, the group collaborates and exchanges information on a regular basis. The range of topics covers all areas relevant to MDR implementation, such as manufacturer obligations, quality management, and the use of the UDI database. New guidelines and requirements at the European and national levels are presented and discussed within the group.  

Optical Materials under RoHS Working Group
The Optical Materials under RoHS (Restriction of Hazardous Substances) Working Group focuses on the further development of EU substance regulations in the field of optical materials. The primary focus of this working group is therefore the regular preparation and submission of RoHS exemption applications for the substance classes relevant to the photonics industry. The goal is to provide companies potentially affected by such regulations with a high degree of planning certainty and to minimize their administrative burden.

Environmental Law Working Group
The Environmental Law Working Group serves as a cross-association forum for sharing information and discussing regulatory requirements in this field. These include, for example, developments relevant to product manufacturers and distributors in the area of substance restrictions—including those under REACH, RoHS, California Proposition 65, and the EU Chemicals Strategy for Sustainability—as well as packaging and waste legislation and other initiatives related to the European Green Deal. In addition, practical implementation issues faced by companies are discussed, and potential solutions are explored. Topics deemed particularly important by members are explored in greater depth through presentations by external experts. Between meetings, members receive up-to-date information on developments in environmental law and have the opportunity to provide input on specific legislative measures and current issues.

Working Group on Vigilance and Post-Market Surveillance
The EU Medical Device Regulation requires manufacturers to implement a post-market surveillance system that sets forth comprehensive requirements to ensure the quality, performance, and safety of a product throughout its entire lifecycle. The “person responsible for regulatory compliance” (Art. 15 MDR) plays a central role and, as the interface between manufacturers, customers, and the competent authorities, is responsible for collecting and evaluating data and feedback regarding risks associated with medical devices. If necessary, measures to minimize risks must be initiated, coordinated, and reported. Once a year, the persons responsible under Article 15 of the MDR from the member companies meet to exchange experiences.