eu Archives - Page 4 of 31 - In Compliance Magazine

EU Proposes Revisions to REACH Annex

The Commission of the European Union (EU) has sent to the World Trade Organization (WTO) a proposal to revise Annex XVII of its Regulation on the Evaluation, Authorisation, and Restriction of Chemicals (REACH) ... Read More...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European Union (EU) have approved a proposal by the European Commission to delay by one year the date of application o... Read More...

EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745, also referenced as the MDR) that effectively extends the transition period for certain Class 1 medical devices. ... Read More...

EU Sets Limits on Formaldehyde used in Toy Materials

The Commission of the European Union (EU) has set limits for the use of formaldehyde in different toy materials. Published in November in the Official Journal of the European Union, Commission Directive (EU)... Read More...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

EU Commission Updates Harmonized Standards List for Toys

The Commission of the European Union (EU) has published an updated list of harmonized standards that can be used to demonstrate conformity with the essential requirements of its directive relating to the safety... Read More...

EU Commission Clarifies Status of Substance Under REACH Regulation

The Commission of the European Union (EU) has clarified the exempt status of a specific chemical under its REACH requirements. In a Regulation issued in early October, the Commission modifies Annex V of Regu... Read More...

EU to Expand Lead Restrictions Under REACH

The European Union (EU) has announced its plans to expand the scope of lead restrictions under the EU’s Regulation (EC) No 1907/2006 (also known and the REACH Regulation). In a Notification submitted to the ... Read More...

Product Standards and Safety Marking, Post-Brexit

The United Kingdom’s House of Commons has released a briefing paper that addresses product safety testing and marking issues in a “no-deal” post-Brexit scenario. Published in mid-June, the paper begins with ... Read More...

EU Commission Updates REACH Restrictions

The Commission of the European Union (EU) has once again modified the restrictions on the use of certain hazardous chemicals contained in Regulation (EC) No. 1907/2006, better known as REACH (Registration, Eval... Read More...

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