Are clinical trials required for medical devices?
When studying new drugs, a clinical trial is required. However, when studying medical devices, clinical trials may not be required, depending on the risk stratification (or class) of the device. In the U.S., all Class III (and some Class II) devices require a clinical trial.
How do I get a medical device approved in the EU?
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product.
What regulations govern clinical trials in Europe?
The Clinical Trial Regulation (Regulation (EU) No 536/2014) aims to standardize the assessment and supervision processes, improve co-ordination and increase transparency for clinical trials throughout the EU, by introducing a common Portal/Application called Clinical Trials Information System (CTIS).
What is European Medical Device Regulation?
The European Medical Device Regulation (EU MDR) is intended to ensure a high standard of quality and safety for medical devices being produced in or supplied into the European Single Market.
Do Class 1 devices require clinical trials?
Not all medical devices will require clinical trials before they may be approved for market release. Class I devices are such low risk that they don’t require clinical trials.
What qualifies as a medical device?
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
What is the current status of the new EU regulations regarding medical devices in the EU?
The IVDR will be fully applicable on 26 May 2022, after a five-year transition period. The MDR and IVDR represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years.
What is a clinical trial application in Europe?
The key documents for a clinical trial application to regulatory authorities in the EU are: the cover letter, the application form, the study protocol, the IB/SmPC, the manufacturer/importer authorizations, the Qualified Person Declaration, the IMPD, the drug labels, and the evaluation fees (payment receipts).
What are regulations in clinical trials?
Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements. It has 12 appendices, formats for clinical trial protocols, informed consent forms, ethics committee (EC) approval templates and a format for serious adverse event (SAE) reporting.
Why EU MDR is needed?
The EU MDR regulations are intended to improve the safety and performance of medical devices in Europe and intends to provide a high level of protection for the health of patients and users of these medical devices.
How do you classify a medical device in Europe?
Determining your device classification for Europe Most devices fall under the Medical Devices Directive (MDD) 93/42/EEC, but some high-risk implantable products must follow the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. The In Vitro Diagnostic Directive (IVDD) 98/79/EC applies to IVDs.
What are the regulations for clinical trials in the EU?
The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive Search for available translations of the preceding link EN ••• and the Clinical Trials Regulation Search for available translations of the preceding link EN •••, became applicable on 31 January 2022.
What are the new regulations on medical devices in Europe?
The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA and for national competent authorities .
Where can I find more information about clinical trials in Europe?
For more information, see European Commission: Clinical trials – Major developments. EMA consultations The Agency consults on its proposals with EU Member States, the European Commission and stakeholders representing non-commercial and commercial clinical-trial sponsors, healthcare professionals and patient groups.
When does the EU Clinical Trials Directive 2022 come into effect?
When the Regulation becomes applicable on 31 January 2022, it will repeal the existing EU Clinical Trials Directive (EC) No. 2001/20/ECand national legislation that was put in place to implement the Directive.