MEDICAL TECHNOLOGIES EVALUATION PROGRAMME
NOTIFICATION FORM
Sponsor information
Contact Name
Contact e-mail
Contact No.
Date
Company
Address
Technology Name
Please state
whether you are?
Manufacturer
Health care staff
Other (please specify)
Distributor/ Agent
Patient/Carer
If you are the distributor/agent, please provide contact details for the manufacturer. They
will be copied into key correspondence:
Technologies likely to be selected for the Medical Technologies Evaluation Programme (and hence
for evaluation by NICE) are those which could result in significant advantages to patients and/or to
the healthcare system. The claimed advantages which they offer over current practice need to be
clearly described, easily understood and plausible. High quality clinical evidence supporting these
claimed advantages will increase the likelihood of a technology being judged as suitable for
evaluation. Information about costs (even indicative costs, in the first instance) is also useful in
judgements about selection.
The NICE technical team will use this notification to compile a briefing note, which along with
expert opinion and patient input, will be presented to the Medical Technologies Advisory
Committee and inform their decision as to whether the product notified is suitable for national
evaluation by either itself, or one of the other guidance producing programmes within NICE.
The Committee’s decision to select a technology will be made by considering its effect on the
current NHS care pathway, as well as the potential patient and system benefits offered by the
technology over a comparator (that is current NHS clinical practice).
Please refer to the programme process guide for further details of the steps involved in the
selection and routing of technologies for evaluation, and also the evaluation of technologies which
are selected and routed to MTEP programme. The methods guide describes the principles and
methodological concepts underlying each stage of the selection and evaluation of technologies.
For instructions on completing and submitting this form, please refer to
Appendix 1.
Page 1
1.
General technology information
1) Please state indication(s) for
use
2) Does the technology have a
CE Mark (as a medical
device*)?
i)
Yes
No
If yes, please enclose CE certificate
ii) If yes, please state the
class of the medical
device (where
appropriate):
Class I
Class IIa
Class IIb
Class III
iii) If yes, please state which
EC directive the device is
(or is intended to be)
covered by:
Medical device (2007/47/EC):
Active medical device (90/385/EEC):
In vitro diagnostic medical device (98/79/EC):
iv) If no, when is CE mark
expected? (month &
year)
3) Has the technology been
launched to, and is available
to, the NHS?
i)
No
Yes
No
If yes, please state the
names of hospital(s) /
organisation(s) in which
the technology is being
used. Please provide
key contact details
4) Is the technology in use
outside the UK?
i)
Yes
If yes, please state which
countries
5) Please provide details of any
patents filed for this
technology**
* To be eligible for acceptance into the programme the technology must CE marked (or expect to be CE marked) as
either; a medical device (under EC directive 2007/47/EC), an active medical device (under EC directive 90/385/EEC), an
active implantable medical device, (under EC directive 90/385/EEC) or an in vitro diagnostic medical device (under EC
directive 98/79/EC). Please refer to our process guide for a more detailed description.
** Patent information is not included in any public documents, but is considered by the NICE team in developing the
briefing note.
Page 2
2.
Other evaluations of the product
Whether a technology is selected for evaluation may be affected by whether other assessments
are being carried out by other national organisations – a decision will be made on application.
Please let us know if an evaluation of the technology has been completed previously, is being
carried out currently or is planned for the future, by any national organisation within the UK (such
as NICE, National Screening Committee, Health Protection Agency, UK Genetics Testing Network,
National Institute for Health Research (NIHR) or the HTA Programme)
Yes
No
If yes, please specify:
3.
Description of the technology and its intended purpose
3.1
Please describe what the technology comprises; how it works; how it is used to treat,
diagnose or otherwise assist in management.
Please provide a copy of the instructions for use for the technology for the indication (s) for
which it is being notified.
3.2
Please describe the properties or features that make the technology innovative or a
significant modification when compared with other technologies of its type.
4.
Condition and /or types of patient
Please describe the target patient population, disease or clinical problem for which the technology
is intended.
5.
Comparator treatment and /or management
5. 1
The comparator is the standard intervention against which the notified technology is
compared. The comparator is usually a similar or equivalent technology used in current
NHS practice (and defined in existing NICE guidance or clinical guidelines from other UK
bodies). In some cases the comparator may be no intervention, for example, best
supportive care.
Please note, if current practice is not defined by existing guidelines, you may wish to seek
advice from clinical experts in the area.
Page 3
5. 2
Please describe the place of the technology in current NHS clinical practice and in the
pathway of care.
For example, will the notified technology work alongside or replace the comparator used in
current NHS clinical practice.
5.3
Please list the names of all technologies which are similar or equivalent to the notified
technology, and how these differ from the notified technology (in terms of their
functionality).
6.
Claimed additional patient benefit
Please describe the extent to which the technology has measurable benefits to patients over
technologies, treatment or management currently in use within the NHS, in terms of its impact on
quality or quantity of life. For example, better outcomes [please specify], less painful, easier to use,
improved quality of life.
Please provide 3 to 4 bullet points stating the benefit and the practical consequences of this benefit
for patients compared with current NHS clinical practice.




Please list references to published studies, trials in progress and registers supporting these
benefits in Section 12 below.
7.
Claimed healthcare system benefit
Please describe the extent to which the technology has measurable benefits to the healthcare
system over technologies or management currently in use within the NHS. For example, reduces
time in hospital or hospital visits; outpatient use rather than inpatient; reduces need for staff
(number, type); or replaces a number of other tests (please describe and specify how).
Please provide 3 to 4 bullet points stating the benefit and the practical consequences of this benefit
for the healthcare system compared with current NHS clinical practice.


Page 4


Please list references to published studies, trials in progress and registers supporting these
benefits in Section 12 below.
8.
Sustainability agenda
Please describe the extent to which the technology is likely to contribute to the sustainability
agenda. For example less energy usage or less waste compared with currently used technologies
or management.
Please provide 3 to 4 bullet points stating the benefit and the practical understandable
consequences for the sustainability agenda compared with current NHS clinical practice.




9.
Cost considerations
9.1
Please complete Table 1 below to give an indication of the costs of the notified technology
and how these compare with the cost of the comparator (defined in section 5.1).
Please note, more detailed information in the form of an economic model is not required at
this stage.
Page 5
Table 1 Unit costs of technology
Items
Notified Technology (insert name)
Comparator (insert name)
Value
Value
Source
Source
List price of
technology
[If part of a system,
please state the list
price for the system
and that of individual
components ]
Consumables (if
applicable)
[Please state the list
price per consumable]
Service/maintenance
cost and frequency (if
applicable)
Anticipated life span of
technology
Average length of use
per treatment
Average frequency of
use
Total cost per
treatment/patient
9.2
Please include any other costing comments below. For example, would the technology
require changes to the way in which current services are organised or delivered? Are
additional facilities or technology required for the benefits to be realised? Does the
technology require staff training?
Please list references to any studies on costs, comparative costs or cost-effectiveness in Section
12 below.
10.
Patient safety: risks associated with the technology
10.1
Please describe potential adverse events for patients, including any reported to a notified
body or other regulatory authority or in the published literature or known to you from other
sources (please include references in the Appendix below). Please indicate their likely
frequency.
Page 6
10.2
Please also describe any particular risks or potential adverse events that might affect the
healthcare system, its staff or its facilities as a result of using the technology.
11.
Were patients consulted during the development of the
technology?
Was advice from patients or patient organisations used in the development of this technology (for
example, patient preferences and views on the acceptability or any other aspects of the
technology)?
If so, please indicate how the patient input was obtained, how many patients were involved and
how patient views influenced the development of the technology.
12.
Equality and Diversity Issues?
NICE is committed to promoting equality of opportunity and eliminating unlawful discrimination on
the grounds of age, disability, gender reassignment, race, religion or belief, sex, and sexual
orientation, and to comply fully with legal obligations on equality and human rights.
Equality issues require special attention because of NICE’s duties to have due regard to the need
to eliminate unlawful discrimination, promote equality and foster good relations between people
with a characteristic protected by the equalities legislation and others. For further information,
please see the NICE website (www.nice.org.uk/aboutnice/howwework/NICEEqualityScheme.jsp).
Please state below whether there are any equalities issues relating to the use of this technology?
13.
References
Please list any references supporting your notification in the table below, Please clearly mark any
references which contain confidential data which is being provided on an “Academic in
Confidence (AIC)” basis – Please see ‘APPENDIX 1 - Guidance on Completion of the
Notification form’ for details. Trials should be identified by the first author or trial ID, rather than by
relying on numerical referencing alone (for example, ‘Trial 123/Jones et al.126’ rather than ‘One
trial126’).
In particular, please list any studies comparing the use of your technology with others in current
NHS use.
Page 7
Patient
benefits
E.g. Journals - Authors (year) ‘Title’ Journal, Volume, Pages.
E.g. Conference abstract (in a journal) – Authors (Year) Title,
Journal title, Volume, Supplement, (Abstract).
System
benefits
Cost
considerations
Patient safety
Page 8
14.
Manufacturer nominated expert advisers
NICE will contact expert advisers and ask them to complete a questionnaire on the technology
which will be used to inform the Medical Technologies Advisory Committee when deciding whether
to select the technology for evaluation. Ideally expert advisors should have experience of both the
technology and the NHS care pathway in which the technology is likely to be used.
If you would like to nominate any expert advisors please provide their details below. All expert
advisers must be ratified (as eligible to provide expert advice) by the professional society (in the
UK) of which they are a member. NICE will contact the professional society to arrange ratification.
Expert Adviser 1
Name:
Job Title:
Employer:
Email address:
Professional/ Specialist Society:
Expert Adviser 2
Name:
Job Title:
Employer:
Email address:
Professional/ Specialist Society:
Expert Adviser 3
Name:
Job Title:
Employer:
Email address:
Professional/ Specialist Society:
Page 9
APPENDIX 1 - Guidance on Completion of the Notification form
The instructions below are intended to provide guidance on the notification of a technology to the
National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies
Evaluation Programme process. If you have any queries or require any assistance when
completing this form please contact us at medtech@nice.org.uk.
NICE acknowledges that due to the wide range of device and diagnostic technologies available,
particular sections of this notification form might not be as relevant for some medical technologies
as they are for others. Where possible, sponsors of medical technologies should respond to the
best of their ability in the context of the question being addressed. Sections that are not considered
relevant should be marked ‘N/A’ and a reason given for this response.
The notification form should be completed with reference to the NICE document
‘Medical Technologies Evaluation Programme – Methods Guide’ particularly with regard to Section
3 ‘Selecting and routing medical technologies in the Medical Technologies Evaluation Programme’.
Users should see NICE’s ‘Medical Technologies Evaluation Programme – Process Guide’ for
further details on some of the procedural aspects of selection and routing of technologies referred
to only briefly here.
Information on CE marking can be obtained from the Medicines and Healthcare Regulatory Agency
(MHRA) at www.mhra.gov.uk.
The notification must be a stand-alone document. Additional appendices may only be used for
supplementary explanatory information that exceeds the level of detail requested, but that is
considered to be relevant to the submission. Any additional appendices should be clearly
referenced in the body of the submission and should not be used for core information that has
been requested in the notification form. For example, it is not acceptable to attach a key study as
an appendix and to complete the clinical-effectiveness section with ‘see appendix X’. Clinical trial
reports and protocols should not be submitted, but made available on request.
Submission of published or unpublished papers:
Please do not submit published papers unless:
 you can confirm that you are an author and have the publisher's permission to share the
article, or
 the appropriate copyright-fee has been paid allowing you to share the article.
Submission of confidential data:
To ensure that the medical technologies selection and guidance process is as transparent as
possible, the Institute considers it highly desirable that evidence pivotal to the Medical
Technologies Advisory Committee’s decisions should be publicly available. The Institute expects
the sponsor to keep confidential material within their Notification to an absolute minimum. Types of
information that can be classed as confidential include:
 Data that are ‘commercial in confidence’ (CIC)
 Data that are intellectual property awaiting publication (‘academic in confidence’).
Information designated as either commercial or academic in confidence should be consistent with
the following principles:
Page 10


Information that has been put into the public domain, anywhere in the world, cannot be
marked as confidential.
The results of clinical trials submitted relating to the product that has received regulatory
approval should be available for scrutiny. When it has been decided that the release of
trial results will occur through a journal publication, as a minimum, a structured abstract
should be available for public disclosure. The content of the structured abstract should be
a synopsis derived from a recognised format for a full trial report, such as that provided by
the CONSORT statement (http://www.consort-statement.org).
Confidentiality agreement
All information submitted at this stage will be treated in confidence and will only be used to inform
the committee’s decision making.
The notification process is confidential between the manufacturer, NICE, its independent advisory
committee and expert advisors, all of whom are bound by confidentiality agreements.
If an eligible topic is not selected, the selection decision is published only by prior agreement with
the sponsor and only with a brief reason for non-selection.
No information is published about topics notified to the programme that do not meet the eligibility
criteria.
All manufacturers must read and complete the confidentiality agreement enclosed.
Submitting the completed Notification form
The notification should be as brief and informative as possible. The completed notification form
should be sent to medtech@nice.org.uk electronically in Word format, and not as a PDF file. If you
are providing a handwritten signature on the Confidentiality acknowledgement and understanding
form at the end of this form, it can either be scanned and sent as a pdf to medtech@nice.org.uk or
faxed to 0207 0619723.
Please ensure you have included the following documents before submitting your notification:
Completed Notification form (in word format)
Confidentiality and Understanding form
Copy of your CE marking certificate
Instructions for use (for the notified indication)
You must tick the following declaration regarding any supporting documentation:
I understand that if I have submitted any publication or other information in support
of this notification I have obtained the appropriate permission or paid the appropriate
copyright fee to enable my organisation to share this publication/information with NICE.
Page 11
Confidentiality agreement form for organisations
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
Confidentiality Acknowledgment and Undertaking
1) We, [insert name of organisation] (the "Organisation"), acknowledge that information may be
disclosed to us in relation to our participation in the work of the Institute which is confidential
(“Confidential Information”). Often this material will be commercially sensitive, or provided to
the Institute on an academic-in-confidence basis (for example research that has not yet been
published). Confidential Information may include, but is not limited to::
(a)
(b)
(c)
(d)
(e)
(f)
the fact that a technology has been notified to the programme and is being considered (pre
selection)
the Medical Technologies guidance overview document (pre publication);
the Medical Technologies guidance consultation document (pre publication);
the final Medical Technologies guidance document (pre publication);
the Medical Technologies guidance draft scope;
information relating to the existence, content or outcome of confidential discussions.
2) Subject to paragraph 3 below, we undertake to the Institute that we shall:
(a)
(b)
(c)
(d)
(e)
(f)
keep all Confidential Information strictly confidential and, except as expressly permitted
under this agreement shall not disclose, use, copy in whole or in part or modify or adapt any
Confidential Information in any way without the Institute's prior written consent which may be
given or withheld in its absolute discretion;
not use any Confidential Information for any purpose other than participating in the work of
the Institute;
limit access to any Confidential Information to such individuals within the Organisation as
require access for the purpose set out in paragraph 2)(b) above;
procure that any individual within the Organisation with access to any Confidential
Information complies with this agreement;
return all Confidential Information to the Institute on written demand; and
in the event that the Institute authorizes any disclosure of Confidential Information by the
Organisation to a third party we shall procure that such third party complies with this
agreement as if he were a party to it.
3) The undertakings set out in paragraph 2 above (the "Undertakings") shall not apply to
information which:
(a)
(b)
(c)
(d)
is in the public domain otherwise than through a breach of any of the Undertakings or a
breach of any other confidentiality obligation owed by any person to the Institute;
was lawfully within our possession before it was disclosed to us by the Institute, and neither
the Organisation nor our alternative source of the information owed any confidentiality
obligation to the Institute in respect of it;
is required to be disclosed by any court of competent jurisdiction or any government agency
lawfully requesting the same provided that we use our best endeavours to notify the Institute
in advance of such disclosure; or
is approved for release by prior written authorization of the Institute.
4) The Institute acknowledges that if the Organisation is a public authority as defined by the
Freedom of Information Act 2000 ("the Act") then the Organisation will have to deal with any
request for the Confidential Information in accordance with the Act.
(a)
The Institute considers that as it is careful only to undertake to keep information confidential
where there is good reason to do so, any request for Confidential Information is likely to be
exempt from disclosure under section 41 of the Act.
Confidentiality agreement form for organisations
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
Confidentiality Acknowledgment and Undertaking
(b)
(c)
If the Organisation receives a request under the Act for Confidential Information and its
initial view is that the Confidential Information should be released then it shall:

promptly notify the Institute of this fact, providing a copy of the request and of the
information requested;

allow the Institute a period of five working days to make representations on how it
considers the request should be responded to;

conscientiously consider those representations; and

if it decides to release any Confidential Information, provide the Institute with a copy of
that information and the covering letter sent to the applicant.
If the Organisation decides not to release Confidential Information in response to a request,
it shall notify the Institute if the requestor challenges that decision by appealing to the
Information Commissioner or the Information Tribunal.
5) We acknowledge that:
(a) breach by the Organisation of any of the Undertakings could cause the Institute harm that is
irreparable and that cannot be compensated by damages, and that in the event of any
actual or threatened breach by the Organisation of any Undertaking the Institute shall be
entitled to apply for and obtain (regardless of any rights the Institute may have to claim
damages) an injunction or other equitable relief against the Organisation;
(b) this agreement constitutes the entire agreement between the Organisation and the Institute
relating to the Confidential Information;
(c) any amendments to or waiver of any of the terms of this agreement must be set out in
writing and signed on behalf of the Organisation and the Institute;
(d)
this agreement is governed by English law and subject to the exclusive jurisdiction of the
English courts.
Signature: [Insert Electronic Signature]
A duly authorized officer for and on behalf of: [Insert Organisation Name]
Print Name: [Insert Name]
Date: [Insert Date]
Please insert an electronic signature above. Alternatively, please print this confidentiality agreement
and provide a handwritten signature above. A typed signature cannot be accepted
If using a handwritten signature, this confidentiality agreement can either be scanned and sent to
medtech@nice.org.uk or faxed to 0207 0619723.