European Clinical trials with DRUGS are now governed by the EU Clinical Trial Regulation (CTR) 536/2014

 

European Clinical Investigations with Medical Devices are now governed by the Medical Device Regulation (MDR) 2017/745 + update 2023/607

• Replaced EU’s MDD 93/42/EEC and EU’s directive on active implantable medical devices (90/385/EEC)
• Promotes a shift from the pre-approval stage to a life-cycle approach
• Greater emphasis on clinical data and the Clinical Evaluation
• Will include a specific group of devices (Annex XV; e.g. contact lenses)
• New definitions and expansions to existing definitions
• Monitoring for defective products
• Metamorphosis of the NBs from industry partner into a police-like extension of the Competent Authorities marker surveillance apparatus
• Safety reporting required pre- and post-market (e.g. periodic safety update report)
• A quality Management System: to be initiated really soon in your product development
• MedDev 2.7/1 Revision 4 and the Medical Devices Regulation will diverge in some areas: knowledge of both will be important during the transition.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

Plan ahead to ensure compliance for MD currently under development and don’t forget that this legislation will also be applicable to your current and historic products.

EU regulation 2023/607 of 15 March 2023 has extended the MDR transitional period as displayed in the figure below.

 

 

European Clinical evaluations with In Vitro Diagnostics are now governed by the In Vitro Diagnostic Regulation 2017/746 + update 2023/607

• Replaced directive on In Vitro Diagnostic Medical Devices 98/79/EC
• Changes of classification form previous Annex II or not listed, to a risk-based classification (Class A-B-C-D)
• Clinical evidence, scientific validity, analytical and clinical performance (Annex XII)
• Clinical evidence report (annex VIII)
• Recording and reporting of events
• New definitions

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&qid=1679386876857&from=EN

The IVDR is into force since 26 May 2022.

 

EU Regulation 2023/607, which amends EU Regulation 2017/746, allows devices that have been placed on the market before or during the transitional period and are still in the supply chain to be further made available on the market.

Plan ahead to ensure compliance for IVD’s currently under development and don’t forget that this legislation will also be applicable to your current and historic products.

 

European Regulation on personal data protection (EU/016/679)

The GDPR (General Data Protection Regulation) is directly applicable to all Member States of the EU without the need for implementing national legislation. It will take effect on May 25th, 2018.

The aim of the law is to ensure the rights to European citizens on data privacy and to be better informed about the use made of their personal data.

It sets clear responsibilities to people and entities handling/storing personal data of EU citizens.

To be crystal clear, your company is concerned by this act if:

• you are a EU company with EU activities;
• you are a non-EU company collecting personal Data of EU citizen (patient data, CV from your European outsourcers, Investigator’s data in your TMF, etc.).

Please find below a link to a PDF slide deck Ad Hoc Clinical has prepared, summarizing the requirements and the impacts of the GDPR on the conduct of your clinical trials.

download GDPR slide deck

ECCRT is offering a webex based course on “how to implement GDPR in your organisations”, training presented by Nancy Cottigny.