Terms and conditions1. Definitions
1.1 “The MHRA” is the Medicines and Healthcare Products Regulatory Agency. The 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 United Kingdom’s Competent Authority for Medical Devices.Online Registrations
1.3 The Online Registration System allows manufacturers and assemblers of medical devices or their authorised representatives to:
- Create an account as a Service User of the system by providing contact details and other relevant company information, which the MHRA will check independently;
- Once the account has been activated, submit registrations of class I medical devices, custom made medical devices and active implantable medical devices, IVDs, and activities covered by Article 12 of the Medical Devices Directive 93/42/EEC, securely to the MHRA on-line and;
- Access all registrations that the company of the “Service User” has submitted or drafted and saved.
1.4 Companies may wish to create more than one account to allow employees access to their registrations.Registration
1.5 With regards to the Online Registration System, “Registration” refers to the requirements under The Medical Devices Regulations 2002, regulations 19, 30 and 44, to provide the Secretary of State with information on the address of the manufacturer and/or authorised representative and the devices concerned.Service User
1.6 A person authorised by the MHRA to use the Online Registration System and given an account and account number.
1.7 The MHRA reserves the right to refuse access to the On-Line Registration System and to terminate an account at its absolute discretion.Confidentiality
1.8 Keeping information secure is important to the MHRA as the Competent Authority for Medical Devices. The MHRA has, therefore, developed the Online Registration System in a way designed to ensure that only Service Users will be able to access the information stored within their account workspace. Access to this system is monitored and controlled, and only persons authorised by the MHRA are allowed access to the system.
1.9 Article 2.20 of Directive 2007/47/EC amends Article 20 of Directive 93/42/EEC relevant to confidentiality. The amendment specifically states that information on the registration of persons responsible for placing devices on the market shall not be treated as confidential. Accordingly the MHRA may release to the public information supplied to it as the Competent Authority for registration purposes from 21 March 2010 when the amending legislation comes into effect. The names of individuals, their telephone numbers and email addresses will remain confidential. Thus the MHRA as the Competent Authority will only release the name and address of manufacturers and authorised representatives and the corresponding medical devices registered with the MHRA.Protection of Personal Data
1.10 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 under these Terms and Conditions of Use.2. The MHRA agrees to the following:
2.1 The MHRA agrees that submission of a new registration or update to an existing registration via the Online Registration System will be considered a valid registration once the details have been checked by the MHRA and payment of the associated fee has been received. The Service User complies with the requirement to register with MHRA by submitting a registration via this service.
2.2 The MHRA agrees 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.
2.3 The MHRA agrees that only registrations created on the Online Registration System that have been submitted to the MHRA will be treated as official registrations. All other draft registrations and any attachments that have been saved on the system but not been submitted to the MHRA will not be treated as official registrations. They will reside on an independent Internet server and will be subject to current data protection laws.
2.4 The MHRA will acknowledge receipt of a registration in writing.3. By creating an account to use the Online Registration System, you are indicating your Agreement to the following Terms and Conditions:
3.1 Submission of new registrations or updates to existing registrations via the system is a valid registration. The Service User complies with the requirement to register with the MHRA by submitting a registration via this service.
3.2 If the Service User is notified that information that it has sent to the MHRA is incomplete, inaccurate, or corrupted, it must take prompt action to submit a corrected registration.
3.3 The level of protection provided by the SSL, User Name, Account Number, and Password system meets the requirement in the Medical Device Directives to observe confidentiality.
3.4 The Service User is responsible and accountable for all use of its User Name, Account Number and Password. The Service User must take sensible measures to protect these if you wish to protect the data it places in the system. To submit data to the MHRA using the system the Service User may only use the access 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 the 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.
3.6 Without prejudice to clause 3.5 above, the Service User shall not:
3.7 The Service User may not reproduce, duplicate, copy, sell, resell, visit or otherwise exploit for any commercial purpose the system or any portion of the system without the MHRA’s express prior written consent.
3.8 The Service User shall only use the system for lawful purposes. The Service User shall not use the system for:
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 the Service User from their general obligations 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 which is the result of the negligence of the MHRA that the Service User of this service may suffer as a result of its use. By using this service, the Service User specifically accepts all legal and general liability for any loss that may arise from such use.5. Copyright
5.1 All content included on the MHRA website, such as text, graphics, logos, button icons, images, audio clips, digital downloads, data compilations, and software, is the property of the MHRA and is protected by United Kingdom and international copyright, authors’ rights and database right laws. The compilation of all content on the MHRA website is the exclusive property of the MHRA and is protected by United Kingdom and international copyright and database right laws.
5.2 The Service User may not systematically extract and/or reutilise parts of the MHRA website without the MHRA’s express prior written consent. In particular, the Service User may not utilise any data mining, robots, or similar data gathering and extraction tools to extract (whether once or many times) for reutilisation any substantial parts of the MHRA website, without the MHRA’s express prior written consent. The Service User may not create and/or publish its own database that features substantial parts of the MHRA website without the MHRA’s express prior written consent.6. Alternative Dispute Resolution
6.1 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.7. Governing Law and Jurisdiction
These Terms and Conditions of Use shall be governed by and construed in accordance with the Laws of England and Wales, the MHRA and the Service User expressly agree to submit to the exclusive jurisdiction of the Courts of England and Wales.8. Refunds
8. 1 All refunds regarding registrations submitted under regulation 19 and/or 44 of the MDR 2002 are discretionary. MHRA will review all refund requests on a case-by-case basis and reserve the right to decline any refund for any reason. If a refund request is declined, a full explanation will be provided by MHRA.
8. 2 The MHRA will not be liable for refunds in cases where there has been a change in EU device determinations, changes to the submitted registration, or where the device has been incorrectly classified by the manufacturer or authorised representative.