Product Compliance Conference

Global Product Compliance – Regulatory trends in selected regions
Dipl.-Ing. (FH) Torsten Sahm, Globalnorm GmbH

Status Quo of UKCA Labeling – The New Product Requirements Post-Brexit
Dipl.-Ing. (FH) Michael Loerzer, Globalnorm GmbH

China on the way to becoming a world standardization power - "Chinese Standards 2035" research project
Tim Rühlig, Deutsche Gesellschaft für Auswärtige Politik (DGAP)

Regulatory developments in cyber security for the Radio Equipment Directive 2014/53/EU.
Holger Bentje, PHOENIX TESTLAB GmbH

Current case law on product liability law - corporate or personal liability?
Dr. Carsten Schucht, Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH

Regulatory developments in the area of Material & Environmental Compliance
Inken Green, Volljuristin, Globalnorm GmbH

Strategy and current legal situation on the subject of digital user manuals
Roland Schmeling, Schmeling + Consultants GmbH

Overview of the planned machinery regulation (standardization, cyber security, AI)
Dipl.-Ing. (FH) Michael Loerzer, Globalnorm GmbH

Sector independent topics were examined by the speakers during the first conference day. Joachim Geiß from the Federal Ministry for Economic Affairs and Energy, for example, reported about the current negotiations for the so-called “Goods Package” which covers a revision of the market surveillance in the EU. In addition to that his head of department Boris Böhme introduced the German Market Regulation Forum.

Two compliance responsible persons showed on the basis of examples from their companies how product compliance management can be realized and gave valuable practical tips gained from their learning.

Attorney Philipp Reusch as well as host Dipl.-Ing. (FH) Michael Loerzer addressed the topic of the legal perspective of product compliance on the one hand in the EU and on the other hand regarding the USA in comparison.

The first day was topped off with a discussion regarding “Quo Vadis European Standardization” because there arouse new questions regarding the publication politics of the EU commission since the “James Elliott” ECJ judgement.

In the evening we aimed high and went up on the radio tower for dinner and charming singers of old film songs, inspiring table talks and a breathtaking view of a fabulous sun set and the sea of lights of the capital.

The realization of product compliance in practice was focused on the second day.

In three tutorials each during the morning and afternoon session the participants got helpful knowhow for mastering real challenges like mandatory registrations with respect to WEEE, Chemical Compliance, the new REDCA TGN01, marketability of consumer products as well as the development of instructions according to IEC/IEEE 82079-1 and the search and monitoring of market access conditions.

Following this, one had the opportunity to talk about specific subjects with the experts of the second day at the Round Tables or to network with other participants.

Precisely how complex product compliance can be was illustrated by Michael Loerzer in his opening address at the 6th GLOBALNORM Product Compliance conference in Berlin, Germany.  The convergence of technologies and achieving proficient regulatory and normative control over them is one of the central challenges of the future.  Take a wooden table, for example.  Attach a light-emitting diode (LED), WLAN and a propulsion motor and you have a high-tech product.

Business relevance was added by Mr. Diedonné of Heraeus Noblelight GmbH.  The lighting system manufacturer now has two Product Compliance Officers on staff, both of whom received their training at the GLOBALNORM ACADEMY – in Quality Assurance Management as well as in Development, Design and Construction.

Dr. Honnacker of the Bavarian State Ministry for Environment and Consumer Protection pointed out the immense responsibility borne by economic operators, and requested a discussion round.  It became clear during this discussion that public authorities play a significant role in terms of providing a safety net (i.e. market surveillance and ensuring fair competition) and are also perceived as a consultative partner.  Univ. Dr.-Ing. Stefan Bracke of the Faculty of Mechanical Engineering and Safety Technology at the Bergische Universität Wuppertal (Chair of Reliability Engineering and Risk Analysis) contributed two product recall examples that cleary showed how failure behavior and prognoses can be calculated using statistical methods.  Mr. Schaber of SICK AG (Dept. External Standards and Regulations) presented the automated drafting of EU Declarations of Conformity for the over 40,000 variants of their product.

Mr. Meinders of the Bundesnetzagentur (Federal Network Agency) was the second representative of a public authority and presented the Radio Equipment Directive 2014/53/EU.  The lively question round after his talk revealed that the Directive, which had come into force on June 13, 2017 was still causing difficulties on occasion.  One issue, for example, was how to handle 'combined equipment' under this new Directive, with the period for comment on this question due to expire at the end of January 2018.  Our legal counsel, Ms Inken Green, presented recent developments in environmental compliance, most notably the amendment to the RoHS Directive.  Other topics included the new Energy Labeling Ordinance, a review of 10 years of REACH as well as potential challenges ahead.

On the second day of the conference, six different workshops focusing on the practical aspects of Product Compliance were on offer to participants:

• Standards Management – Practical issues, organization and objectives from a business point of view
• Product Compliance in the business' structure – As much as is needed and as little as possible
• Market authorization requirements for electrical products in the global movement of goods
• Products with integrated wireless transmission (radio) components – Legally compliant implementation of the Radio Equipment Directive
• Dialog between economic operators and public authorities – Current issues regarding CE marking, obligations of economic operators and liability issues
• Application of the Conformity Assessment procedure without a specific product standard

A Recommendation for Action in German and English, with sample Declaration of Conformity forms, developed in the "Products with Integrated Wireless Transmission Components" workshop will be made available here shortly.