Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

Europe – MDCG 2019-11 Guidance on Qualification and Classification of Software in...

This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical...
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

Europe – EC Unveils First Notified Body Designation Under IVDR

The European Commission (EC) on Thursday revealed that Germany-based Dekra Certification GmbH is the first notified body (NB) to be designated under the EU’s...
Licensing biosimilars, ATMPs and PMFs after Brexit

UK – Medical devices regulation in the event of no deal

Medical devices regulation in the event of no deal All information on this page relating to medical devices continues to apply unless the UK exits...
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

Europe – MDCG 2019 -10 : Application of transitional provisions concerning validity of...

According to Article 120(2) of Regulation (EU) 2017/745 on Medical Devices (the MDR), certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC (the Directives)...
Regulatory Strategies for EU MDR and IVDR Implementation

Europe – Regulatory Strategies for EU MDR and IVDR Implementation

September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical...
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

Europe – MDGC Guidances

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical...
TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

Europe – TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

The European Commission on Thursday announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the EU’s Medical Devices...
MHRA: Role of UK Responsible Person and Importer are the same

UK – MHRA: Role of UK Responsible Person and Importer are the same

The Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s medical device market regulator, has published new details on the role and responsibilities of...
Regulatory Strategies for EU MDR and IVDR Implementation

Europe – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR

A new RAPS/KPMG survey of more than 200 medical device industry leaders found that only 27% said they will be fully compliant with the...
Regulating medical devices in the event of a no-deal Brexit

UK – Regulating medical devices in the event of a no-deal Brexit

This guidance will apply from exit day in line with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 . This guidance sets out how medical devices will...

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