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  • Start Now
  • About
  • Customers
  • Blog
  • Login
  • More +
    • What is CE marking?
    • Benefits of CE marking?
    • Does your product need CE?
    • Can you do CE marking Self-Certification?
    • Which countries require the CE mark?
    • What does CE certification cost?
    • Who is responsible for CE marking?
    • Amazon Responsible Person for CE-marked products
    • CE Marking Directives and Regulations
    • Technical File
    • EU Declaration of Conformity

Medical Devices Directive

(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –

Categories Medical Devices Directive, News, standardisation, Standardization Tags electronic, ElectronicManual, European harmonized standards, medical devices, medical regulations, standards

Irish NSAI Expects Approval to get EU MedTech Certification

Irish NSAI expects approval to get the EU MedTech Certification to carry out certifications under new EU criteria for medical equipment.

The Irish NSAI expects approval to get the EU MedTech

Categories Medical Devices Directive, News Tags EU, Ireland, mdr, MedTech, Notified Body, NSAI, standards

MDCG Addition to IVDR to-do List

MDCG Addition to "IVDR to-do List", official publication of this MDCG news announcement from April 1, 2022. 

MDCG Addition to “IVDR to-do List”, official publication of this

Categories CE Directives, Medical Devices Directive, News Tags CE Marking, EU, European Commission, European harmonized standards, IVDR, MDCG, medical devices

EU-MDR Lurches Towards US-FDA Approach

EU-MDR Lurches Towards US-FDA Approach

The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe in a way that is unacceptable to many market participants.

Categories CE Directives, Medical Devices Directive, News Tags EU, European Commission, FDA, medical devices, standards, UK

Compliance And The Growth Of The Medical Industry

Compliance and the growth of the medical industry, does it collaborate?

Compliance and the growth of the medical industry, does it work together? This question is highly relevant because the growth in the medical device industry is significant. And also, this will continue to be the case for the foreseeable future.

Categories Agency Insight, Articles, Medical Devices Directive, News Tags AI, compliance, medical devices, medical regulations, MedTech

The European Commission confirms proposal to postpone the MDR

The European Commission confirms proposal to postpone the MDR

The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.

Categories Medical Devices Directive, News Tags mdr, medical device, medical devices

Medical devices and IVDs: List European harmonised standards updated

Medical devices and IVDs: List European harmonised standards updated

The European Commission has published an update of the list of European harmonised standards under the Medical Devices Directive (93/42/EC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostics Directive 98/79/EC.

Categories Medical Devices Directive, News, standardisation Tags medical devices, standards

Medical Device Regulation (MDR): new guidance documents published

Today, the European Union’s advisory organ for medical devices, the

Categories Medical Devices Directive, News Tags mdr, medical devices
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  • Start Now
  • About
  • Customers
  • Blog
  • Login
  • More +
    • What is CE marking?
    • Benefits of CE marking?
    • Does your product need CE?
    • Can you do CE marking Self-Certification?
    • Which countries require the CE mark?
    • What does CE certification cost?
    • Who is responsible for CE marking?
    • Amazon Responsible Person for CE-marked products
    • CE Marking Directives and Regulations
    • Technical File
    • EU Declaration of Conformity