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MHRA’s Manufacturer On-line Reporting Environment

(for medical devices and equipment)

Terms & Conditions of Use

1. Definitions and Descriptions

MHRA

1.1 MHRA is the Medicines and Healthcare products Regulatory Agency. MHRA is an Executive Agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

1.2 The MHRA was formed from a merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) on 1 April 2003. MHRA is the UK’s Competent Authority for Medical Devices.

MORE

1.3 MORE is the MHRA’s Manufacturers’ On-line Reporting Environment. MORE allows manufacturers and suppliers of medical devices or their authorised representatives to:

- Request registration as a Service User of MORE and to obtain a reporting account by providing contact details and other relevant company information, which MHRA will check independently;

- Once registered as a Service User, submit recall reports (submitted as final reports), trend reports, and initial, follow-up, and final incident reports securely to MHRA on-line and ;

- via the MORE reporting account, access all reports that the “Service User” has submitted or drafted and saved.

1.4 Some manufacturers may require several reporting accounts as they may wish to register several Service Users as vigilance reporters for different types of medical device.

1.5 The European Union (EU) Medical Device Guidance MEDDEV 2.12-1 describes a system for the notification and evaluation of adverse incidents known as the Medical Devices Vigilance system. An important component of this vigilance system is the obligation, placed on the manufacturer (or their EU Authorised Representative) as part of their post market surveillance activities, to report incidents and recalls to Member States, so called Vigilance reporting. The reporting criteria are spelt out in Council Directive 90/385/EEC of 20 June 1990 (AIMD) Article 8 and Annexes 2,4,5; Council Directive 93/42/EEC of 14 June 1993 (MDD) Article 10, 20 and Annexes II,IV,V; and Council Directive 98/79/EC of 27 October 1998 (IVDD) Article 11,19 and Annexes II,IV,V,VII.

1.6 A person authorised by MHRA to use MORE and given a reporting account and account number. They will normally be a vigilance contact for EU vigilance reporting.

1.7 EU Member States are to ensure that any information brought to their knowledge in accordance with the provisions of the Medical Device Directives, regarding medical device incidents and recalls is recorded and evaluated centrally. The obligations are spelt out in Article 8 (AIMD), Article 10 (MDD) and Article 11 (IVDD) and they concern any medical device which carries the CE marking.

1.8 EU Member States and all parties involved in the application of the Medical Device Directives are bound to “observe confidentiality” with regard to all information obtained in carrying out their tasks. This is a requirement of Article 15 (AIMD), Article 20 (MDD) and Article 19(IVDD). Keeping information secure is of course important to the MHRA as the UK Competent Authority for Medical Devices. MHRA have, therefore, developed MORE and the registration process in a way designed to ensure that only “Service Users” will be able to access the information stored within their reporting account workspace. Access to this system is monitored and controlled, and only persons authorised by MHRA should be able to access the system.

1.9 The MHRA shall comply and procure that its employees, representatives and agents shall comply with by the Data Protection Act 1998 and warrants that it shall duly observe all its obligations under the Data Protection Act which arise from its performance of its obligations under these Terms and Conditions of Use.

2. MHRA Agree

2.1 MHRA agree that submission of a report of an incident or recall via MORE is a valid notification of a "Vigilance" report. You comply with the requirement to notify a "Vigilance" report if you notify it to the MHRA via this service.

2.2 MHRA agree that if manufacturers report vigilance incidents and recalls via MORE successfully this allows MHRA to record and evaluate centrally this information.

2.3 MHRA agree that the level of protection provided by the Secure Socket Layer (SSL), User Name, Account Number, and Password system meets the requirement in the Medical Device Directives to observe confidentiality.

2.4 MHRA agree that reports, all their content and any attachments, that have been saved as drafts but not submitted to the MHRA, will not be accessible to MHRA. They will reside on an independent Internet server and will be subject to current data protection laws. Reports will only become accessible to the MHRA once they have been submitted and properly received.

2.5 The MHRA will acknowledge proper receipt of a report.

3. By logging in and registering to use MORE, you are indicating your Agreement to the following Terms and Conditions:

3.1 Submission of a report of an incident or recall via MORE is a valid notification of a "Vigilance" report. You comply with the requirement to notify a "Vigilance" report if you notify it to the MHRA via this service.

3.2 If you are notified that information that you have sent to the MHRA is incomplete, inaccurate, or corrupted, you must take prompt action to submit a corrected report.

3.3 The level of protection provided by the Secure Socket Layer (SSL), User Name, Account Number, and Password system meets the requirement in the Medical Device Directives to observe confidentiality.

3.4 You are responsible and accountable for all use of your User Name, Account Number and Password. You must take sensible measures to protect these if you wish to protect the data you place in MORE. To submit data to MHRA using MORE you may only use the access to MORE provided by these details.

3.5 Any unauthorised attempt to access or modify computer system information or to interfere with normal system operations, whether on MHRA computer systems or on networks accessible from the MHRA website, may result in the suspension or termination of your access. Access by any persons other than those authorised by the manufacturer and MHRA is prohibited. Depending on the nature of any such activity the MHRA, or any other body with the power to do so, may initiate legal proceedings of whatever kind are appropriate.

4. Limitation of liability

4.1 The MHRA reserves the right without notice to disable or discontinue the service as required. This may be for the purposes of routine maintenance or other reasons, or as part of an emergency termination of electronic computer connections designed to protect resources from illegal access or other damage.

4.2 In the case of an unanticipated service failure the MHRA and/or its agents will endeavour to restore the service to normal operating conditions as quickly as possible. Temporary disruption of the service will not constitute termination of the Agreement or relieve you from your general obligations to report medical device related adverse incidents to the MHRA.

4.3 The MHRA accepts no responsibility for any loss, damage or inconvenience of any kind, except for death or personal injury the result of the negligence of the MHRA, that the User of this service may suffer as a result of its use. By using this service, the User specifically accepts all legal and general liability for any loss that may arise from such use.

5. Alternative Dispute Resolution

5.1 The MHRA and the Service User agree that in the event of a dispute or disagreement as to the effect of any term or condition, or the consequences of the application of any such term or condition, they will jointly seek to resolve the dispute or disagreement by mediation using the services of a mediator appointed by the Centre for Dispute Resolution (CEDR) prior to the initiation of any proceedings in the Courts.