Clinicals In The Uk 26 January 2009

Undertaking a Clinical Study for a Medical Device in the UK Presentation to the UKTI Healthcare Briefing Tour Kevin Webb Head of Regulatory & QA Mediqol Limited

Global Harmonisation
The Global Harmonization Task Force was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems.
But there remains a significant amount of difference between countries in both the regulatory and clinical requirements
transparency between member states also remains an issue (but perhaps not for too much longer)

Clinical Investigation in the UK (and the rest of Europe)
In order to obtain the CE Marking for any device a manufacturer must demonstrate that the device complies with the the relevant Essential Requirements. In order to demonstrate such compliance and particularly with higher risk devices the required clinical data may be be in one of two forms:
either a clinical literature evaluation; or
the results and conclusions of a specifically designed clinical investigation
not enough transparency between member states

Unless safety and performance can be adequately demonstrated by other means such as a clinical literature review, data generated from a specifically designed clinical investigation of a medical device is likely to be required.
However …………..

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK Competent Authority

The Process
Before devices intended for clinical investigation in the UK are made available to an Investigator the legal manufacturer of the device must give 60 days notice to the MHRA
Notification of a clinical investigation to the MHRA is not required where a device is already CE-marked for the intended purpose however relevant ethics committee approvals would still be required in this scenario

The Process cont
The MHRA is very helpful!
Before making an application to the MHRA to conduct a clinical investigation manufacturers should consider a pre-submission meeting or conference call to discuss potential technical, clinical or regulatory issues

Fees!
Manufacturers applying for pre-clinical assesment of clinical investigation notifications by MHRA must pay fees!
Class I, IIa or IIb devices other than implantables or long term invasive £3,000
Class IIb implantable or long term invasive, Class III and active implantables £4,100

Research Ethics Committee Approvals
For all clinical investigations of medical devices a Research Ethics Committee favourable o pinion is also required for each participating centre
This opinion(s) may be obtained in parallel with the MHRA notifiication
BUT the clinical investigation cannot proceed until both MHRA and Research Ethics Committee approval is granted

Integrated Research Application System (IRAS)
Manufacturers can now prepare their applications to conduct a clinical investigation through the on-line IRAS
IRAS is a UK-wide single system that streamlines the process for applying for permissions and approvals
IRAS captures the information needed by MHRA, Ethics and NHS,
R & D

Advantages of performing a clinical study in the UK
Data is respected throughout the world…..including FDA!
IRAS - single system on-line for MHRA, REC & NHS, R & D
only need enter information once – populates all relevant forms
MHRA – defined timelines + user friendly
60 day clock
REC – applications through Central Allocation Service
Authorised RECs specifically trained to review medical device studies
Dates for all REC meetings & submission dates for documentation on-line
Good website and user friendly

Advantages of performing a clinical study in the UK
NHS R & D – becoming more organised
Using ABHI approved version of Clinical Investigation Agreements for financials
Uses NHS cost models
Requires all sites to undergo GCP training
Often provides Study Research Nurses
Follows progress of studies
Investigators and sites
GCP Trained
Produce high quality data
No language issues

However Fundamental Changes are Coming which will mean more products will require a clinical study in order to obtain a CE Mark!
Directive 2007/47/EC
published 21 September 2007
C ompliance mandatory from 21 March 2010

Transparency arrangements
93/42/EEC – Article 14a
EU databank to be implemented by 5 Sep. 2012, and the EU
Commission to evaluate its functionality by 11 Oct. 2012.
info. to be included in the EU databank will now include
manufacturer and EUAR registration data under article 14, and data relating to clinical investigations intended to demonstrate safety and performance.
93/42/EEC – Article 16.5
Each Notified Body must inform its CA and other NBs of the details of all CE Marking certificates issued, amended, suspended, withdrawn or refused.

93/42/EEC – Article 15:6
Concerning clinical investigations conducted in accordance with Article 15 (i.e. with non-CE Marked devices), Member State CAs shall communicate with each other and with the EU Commission the following information:
all decisions to refuse a clinical investigation approval;
all decisions to terminate an approved clinical investigation early on safety grounds;
all decisions involving significant modification or temporary
interruption to an approved clinical investigation

93/42/EEC – Article 20(a) (new).
Member State CAs will exchange such information with each other and the EU Commission to enable uniform application of the Directive.

Clinical Investigation
93/42/EEC – Article 15
The authorisation process for clinical investigations with non-CE Marked medical devices will include a review of the clinical investigation plan.

Clinical Investigation Requirements
93/42/EEC – Article 15:2 & 15:3
The authorisation process for clinical investigations with non-CE
Marked medical devices will include a review of the clinical
investigation plan.
93/42/EEC – Article 15:7
The manufacturer or EUAR must inform the Member State CA
when a clinical investigation taking place in a Member State
ends, including a justification for any early termination of the
investigation.

Clinical Evaluation (Annex X)
For Class III devices, the data for clinical evaluation shall come from
clinical investigation with the device concerned, unless adequate
justification is provided for use of existing data on another device is proven

Clinicals In The Uk 26 January 2009

by Colin Rylett

Accessibility

Categories

Upload Details

Usage Rights

2 Embeds 50

Statistics

Clinicals In The Uk 26 January 2009 Presentation Transcript

http://www.mediqol.com	49
http://www.slideshare.net	1