MDR and IVDR News
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.
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
AATCC Releases Textile Face Covering Draft Guidance
AATCC collaborates with SGS and other industry stakeholders to draft textile face covering guidance. Read More
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment
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
- Personal and Protective Equipment