Clinical trials with DRUGS: EU Regulation 536/2014

Current situation:

Clinical trials with Drugs are governed by the EU Clinical Trials Regulation 536/2014, directly applicable to all member states.

This new regulation was adopted by the EU parliament on the 2nd of April 2014 and is now into force since 31 January 2022.

Previous situation:

Interventional Clinical trials with Drugs were governed by the EU Clinical Trials Directive (EU/2001/20/EC). This directive was to be transposed into national law of each member state leading to a complex regulatory environment.

 

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.

 

 

Clinical Investigations with Medical Devices: Medical Device Regulation (MDR)

• 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.

http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf

The MDR is now into force since 26 May 2021.

Plan ahead to ensure compliance for MD currently under development and don’t forget that this legislation will also be applicable to your previously CE Marked products as well.

 

Performance evaluations with In Vitro Diagnostics: IVD R (regulation!)

• 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

http://data.consilium.europa.eu/doc/document/ST-10729-2016-INIT/en/pdf

The IVDR will become applicable in May 2022.

Plan ahead to ensure compliance for IVD’s currently under development and don’t forget that this legislation will also be applicable to your previously CE Marked products as well