regulations Archives - In Compliance Magazine

MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a document outlining its vision for the future of the EU’s medical technology regulations. In its position paper, titled ... Read More...

EU Moves Toward Regulation of AI

In a major regulatory development, the European Parliament has passed a draft law that would place restrictions on the use of artificial intelligence (AI) in the European Union (EU). According to an article ... Read More...

An Overview of Aerospace Battery Compliance

The United States Federal Aviation Administration (FAA) has published requirements that require testing for all battery devices that are a part of the aircraft itself. This testing is heavily based on standards published by RTCA and includes primary and secondary lithium, nickel, and sealed lead chemistries.

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...

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