CE Marking,EU,GPSR

Are you keeping up with the latest developments in international product safety? The recent International Product Safety Week, organised by the European Commission, brought together key players in the field to discuss and promote consumer product safety on a global scale. The International Product Safety Week serves as a vital ... Read more

Ce Made In China Label.jpg

Often when you buy products or components to be used in your products, they bear the CE marking and the supplier indicates that they are in compliance with European directives and standards. For your company it can be important to receive CE compliant products or components, because you may bear ... Read more

Cevsukca C0d52ad368b3b8938e3c6ffc73ea0a85 2000.jpg

UKCA vs CE MARK, PRODUCT SAFETY AND COMPLIANCE (OPSS) UPDATE PUBLISHED FEBRUARY 2022 After the Brexit, a transition period remained in effect. During this period, EU rules continued to apply throughout the UK. This period ended on December 31, 2020 (even though the UK government approved to extend the transition ... Read more

2021 Amendments Pressure Equipment Directive | Photographer: CHUTTERSNAP | Source: Unsplash The amendments to harmonised standards under the Pressure Equipment Directive (PED) are published in an executive order. These took effect on October 11, 2021. It covers the harmonized standards for: metallic industrial piping systems; bolted connections for flanges and ... Read more

Img 7988 Eb8589886700bab92ce1e1dc7a424a25 2000.jpeg

Unfinished Machinery: Who Is Responsible For CE Marking? What if a manufacturer delivers machines without controls because the customer takes care of this himself or by others. The manufacturer has tags in use with and without the CE mark. The questions that may arise in a case like this are: ... Read more

What is the role of quality assurance and quality management in product safety and product compliance? How does quality management help to make the legal responsibilities of economic operators easier? What developments can we expect in the near future? Mr. Han Zuyderwijk and Mr. Antony Hayes discussed these subjects during ... Read more

Good news for companies exporting CE-marked products to the United Kingdom. Today, the UK regulator has extended the foreseen deadline for the replacement of the CE marking for the UKCA marking with one more year until the 1st January 2023. This means that exporters that sell into the UK have ... Read more

Unsplash Image Ccad384e24ddae24a04047d0edb1a070 2000.jpg

New Recommendations European Union Harmonized Standards For Medical Devices: the Medical Device Coordination Group (MDCG) of the European Commission has issued new recommendations on the role of standards in the medical device industry (the Guidance). The Guidance explains how harmonised European standards (hENs) are governed. It also explaines the advantages ... Read more

What do importers of face masks, gowns, gloves and other personal protective equipment need to know about CE marking? The Z-files podcast has published the interview they did with me that covers this topic in depth. Except for the Corona-hairstyle, which the video editor was unable to fix, I am ... Read more

Borderline .png

On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications. The manual adds six new items: two to help determine medical intended ... Read more