regulations Archives - In Compliance Magazine

EU Commission Updates Regulation on Standby Energy Consumption of Electrical/Electronic Equipment

The Commission of the European Union (EU) has updated its ecodesign requirements applicable to electrical and electronic household and office equipment to address energy use in standby and off modes. Publish... Read More...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its regulations under the EU’s Medical Device Regulation (2017/745, or MDR) and the In Vitro Diagnostic Regulation (2017/746... Read More...

EU Commission Publishes Updated “Blue Guide” on Product Rules

The Commission of the European Union (EU) has recently published an updated version of its guide on the application of EU rules and regulations to a wide range of products. The EU’s “Blue Guide on the implem... Read More...

FCC Regulatory Process: Safety is Just One Consideration

Many people believe that the U.S. Federal Communications Commission (FCC) focuses primarily on public safety considerations when developing regulations to address radio spectrum allocation issues. But, in reali... Read More...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746 (also known as the IVDR), in an effort to ensure ... Read More...

EU Commission Modifies REACH Regulation on CMR Substances

The Commission of the European Union (EU) has amended portions of its regulation on the registration, evaluation, authorization, and restriction of chemicals (Regulation (EC) No 1907/2006, also known as REACH) ... Read More...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently released a document outlining “guiding principles” essential to the development of medical devices using artificial i... Read More...

EU Market Surveillance Regulation Takes Effect

A landmark piece of European Union (EU) legislation intended to strengthen market surveillance of products for compliance with applicable regulations is now in full effect. Issued by the EU Commission in Jul... Read More...

China Certification Authority CNCA Announces Important Changes to CCC Regulations

The latest announcement by Chinese Certification Authority CNCA has a significant impact on many automotive suppliers and car manufacturers. Several products were removed from the list of products that require compulsory product certification. Other products must now obtain a CCC Self-Declaration.

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

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