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Welcome to MDR and IVDR News. Read about the latest highlights and regulatory updates regarding the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR), and find out more about our capabilities as a notified body for medical devices.

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Displaying 13 articles

EU RAPEX Recall Particle Filter Masks from Markets

The EU Rapid Alert System for dangerous non-food products (RAPEX) has recently issued notifications of numerous particle filter masks that do not comply with the Personal Protective Equipment Regulation and the relevant European Standard EN 149, resulting in their recalls from the EU markets. Read More

  1. Personal and Protective Equipment
July 21 2020

CEN, the European Committee for Standardization Releases Guidance for Face Coverings

Industry guidance for reusable fabric face coverings continues to expand as the European Committee for Standardization releases CWA 17553:2020 ‘Community face coverings – Guide to minimum requirements, methods of testing and use’. Read More

  1. Personal and Protective Equipment
July 08 2020

AATCC Releases Textile Face Covering Draft Guidance

AATCC collaborates with SGS and other industry stakeholders to draft textile face covering guidance. Read More

  1. Personal and Protective Equipment
June 23 2020

China Postpones Implementation of New Non-Powered Air Purifying Particle Respirator Standard GB 2626-2019

China issued an updated version of its mandatory national standard GB 2626-2019 Respiratory Protection – Non-powered Air-purifying Particle Respirator. The implementation date of the standard was postponed by one year to July 1, 2021. Read More

  1. Personal and Protective Equipment
June 18 2020

US FDA Issues Revised Face Mask and Respiratory Enforcement Policy

The US FDA has issued “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” May 2020. This revision includes updates regarding alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available. Read More

  1. Personal and Protective Equipment
June 04 2020

China Releases an Updated Mandatory National Standard for Protective Clothing - Static Protective Clothing GB12014-2019

China issued a new mandatory national standard for protective clothing - static protective clothing GB12014-2019. The new standard will become effective on July 1, 2020. Read More

  1. Personal and Protective Equipment
May 26 2020

AFNOR Releases General Purpose Mask Standard

The French association, AFNOR, has released AFNOR SPEC S76-001 “Masques barrières" or “Barrier Masks” (in English), a standard that establishes minimum requirements for non-medical general purpose masks Read More

  1. Personal and Protective Equipment
April 22 2020

China Releases an Updated Mandatory Standard GB 2626-2019 Respiratory Protection - Non-Powered Air-Purifying Particle Respirator

China issued an updated version of its mandatory national standard GB 2626-2019 Respiratory protection - Non-powered air-purifying particle respirator. The revised standard will become effective on July 1, 2020. Read More

  1. Personal and Protective Equipment
April 03 2020

Domestic Oven Gloves – CE Mark – PPE Updates 2018

Domestic oven gloves and mitts have been categorized for risk as Category II Personal Protective Equipment (PPE) and regulated under the new PPE Regulation (EU) 2016/425 with effect from April 21, 2018. Read More

  1. Personal and Protective Equipment
April 11 2018

Domestic Oven Gloves – CE Mark – PPE Updates

Effective April 21, 2018, domestic oven gloves and mitts will be classified as Personal Protective Equipment (PPE) and regulated under the new PPE regulation 425/2016/EU. This regulation will repeal and replace Directive 89/686/EEC. Read More

  1. Personal and Protective Equipment
September 13 2017