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New List of Designated Standards UK Radio Equipment Regulations 2017 (S.I. 2017/1206) - published on Product Compliance Manager: NOTICE OF PUBLICATION 0064/22 of 8 September 2022
https://t.co/HK90Rt8gHW
#UK #OPSS #RadioEquipment #ProductSafety #OPSS #UKconformityassessment

[cemarking.net @cemarking]

New List of Designated Standards UK Toy Safety Regulations of September 1, 2022 - also published on Product Compliance Manager
https://t.co/taJlsg0P9V
We made an overview for your convenience. This is their statutory guidance published on September 1, 2022.
#OPSS #ToySafetyUK

[cemarking.net @cemarking]

Manufacturers of Energy-related Products can now create the UK energy-label online using a new web-based service from the British government.

https://t.co/cxLSWRFAI3

#dishwasher #television #RadioEquipment #Refrigerators #EnergyLabel
#ukenergylabel #UK #GB #England #Scotland

[cemarking.net @cemarking]

(EU) 2021/2226 explained: Electronic Manuals for Medical Devices – published on https://t.co/kO84u5vCMa – May 24, 2022
This Implementing Regulation is in force as of January 2022. What has changed? We made an overview for your convenience.

https://t.co/OuzXEv8ltU

#UserManuals

[cemarking.net @cemarking]

Important Validation Announcement regarding the Toy Safety Directive
This notice, published on https://t.co/kO84u5vCMa, specifically regards the harmonized standards of the flammability requirements and toxic metal migration test for toys.
https://t.co/RpmItqF4lJ
#CEmarking #EU

[cemarking.net @cemarking]

List of Harmonized Standards under the ATEX Directive Updated - This decision specifically regards the harmonized standards for nozzle, test requirements, and dimensions used for specific purposes.
https://t.co/HQRTCMAuwh
#ATEX #HarmonizedStandards #AmendmentsATEX

[cemarking.net @cemarking]

Study on the Functions and Effects of European Standards and Standardization in the EU and EFTA Member States. Our post on https://t.co/kO84u5vCMa outlines the main conclusions for your convenience.
https://t.co/uvAk1Vmnv4

#CE #EuropeanStandardization #EFTA #EU #cemarking #EU

[cemarking.net @cemarking]

The European Commission has recently made updates to the Implementing Decision (EU) 2021/1182. It is replaced by the Commission Implementing Decision (EU) 2022/757 of May 11, 2022.

https://t.co/rAiapNBeF5…

#MDR #IVDR #MDD #AIMD #LVD #AmendmentsLVD #mdr #regulatoryaffairs #EU

[cemarking.net @cemarking]

The European Commission has recently made updates to the Implementing Decision (EU) 2021/1195. It is replaced by the Commission Implementing Decision (EU) 2022/729 of May 11, 2022.

https://t.co/rAiapNBeF5

#MDR #IVDR #MDD #AIMD #LVD #AmendmentsLVD #mdr #regulatoryaffairs #EU

[cemarking.net @cemarking]

The OPSS announced many new and proposed updates for GB as well as for NI, we made an overview for your convenience. This is published on May 10, 2022.
https://t.co/1aFvdLm1o1

#OPSS #GreatBritain #NorthernIreland #ProductSafety #RegulatoryStandards #HarmonizedStandards

[cemarking.net @cemarking]

List of Standards LVD Updated -published on Product Compliance Manager - May 10, 2022

This updated list is important to all manufacturers of CE marked products under the LVD that have used European harmonized standards to prove CE compliance.
https://t.co/EWWNnl3e2H

#LVD

[cemarking.net @cemarking]

-- IMPORTANT IVDR SURVEILLANCE UPDATE --

The MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR – published at https://t.co/kO84u5vCMa – May 5, 2022

https://t.co/cEYxLQmvqh

#MDCG #IVDRsurveillance

[cemarking.net @cemarking]

More Problems Philips Respironics: Sleep Apnea Devices also Remain a Concern. After yesterday’s publication on the recall of the V60 family of ventilators, we now continue with the problems surrounding Respironics’ Sleep-apnea and Respiratory Devices.

https://t.co/dXqkxFsQfN

[cemarking.net @cemarking]

Philips Respironics publicly announced the recall of medical devices in the Ventilator-series. This is not the first time these devices have been in the news due to life-threatening flaws in the technology used.
https://t.co/lBh7FxKQc6

#MedTech #Philips #PhilipsRespironics #FDA

[cemarking.net @cemarking]

The MDCG publishes MDR surveillance guidelines regarding the transitional provisions under Article 120 of the MDR - published at https://t.co/kO84u5vCMa – May 2, 2022 -
(Also available in Dutch language)
https://t.co/JIGC2X8bX2

#MDCG #MDR #MDD #AIMDD #surveillanceguide #2022-4

[cemarking.net @cemarking]

EU roadmap to reduce chemicals – published on https://t.co/kO84u5vCMa – April 29, 2022

This roadmap from the ECHA defines priorities in the period extending to the revision REACH regulation. Stakeholders should prepare for the coming restrictions.
https://t.co/ztLYzGnBqX

#ECHA

[cemarking.net @cemarking]

The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows. We are now almost five years after the adoption of the two regulations.

https://t.co/k3fg4eCDbY

[cemarking.net @cemarking]

On April 22, 2022, the UK based OPSS published new proposals for UK guidance. It is for businesses in regard to the designated standards of Personal Protective Equipment, Pressure Equipment, and Recreational Craft.

https://t.co/dIIHLBOIWS

#newproposals #OPSS #PPE #UKGuidance

[cemarking.net @cemarking]

Three well-known notified body experts discuss how they are trying to make the new regulatory framework work as demand for EU notified body Medtech services rapidly outpaces capacity. The situation is critical

https://t.co/CxtsSzbgI7

#Medtech #medtechupdates #BSI #TuvSud #IMQ

[cemarking.net @cemarking]

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. How must you implement these changes in your current QMS?
https://t.co/oVBcNNcbEJ
#QMS