from the FDA, the EU, Health Canada, and more

Regulatory Updates

Revised ISO 13485:2003 is Coming

The 2016 revised standard of ISO 13485:2003 is coming; ISO 13485 – the internationally recognized quality management systems standard for the medical device industry – has been updated after thirteen years. The final version of this standard was published on March...

New Draft from EU on MDR

The EU Council has released a draft of their position on the proposed MDR and IVDR. On 5 October 2015, the Ministers of the EU countries agreed on the General Approach of the position. The Council, Parliament, and Commission will negotiate the various proposals into...

ISO/FDIS 9001 – What you need to know

The white paper aims to help you better understand the contents and potential implications of the proposed changes to quality management system requirements in ISO/FDIS 9001, issued in July 2015. Download the white paper from SGS...

UDI Deadline Approaching

Are you ready for September 24, 2015? In just over a month, several categories of Class I and II devices will reach their compliance due date for labeling requirements under the Unique Device Identification (“UDI”) regulations. For companies with implantable,...

RTA Policy for 510(k) Submissions

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency. The latest RTA...

EU Updates List of Standards

European officials have published an updated list of recognized and harmonized standards in the Official Journal of the European Union, including standards pertaining to their medical device and IVD Directives. The first part of the new list deals with the Medical...

Reorganization of EU Commission website

The beginning of 2015 welcomes changes to the EU Commission website for medical devices, as well as new OJEU lists! Reorganization of EU Commission website Check your website bookmarks. The EU Commission has recently revised their medical devices...