Changes to 93/42/EEC

as amended by 2007/47/EC

File No. 252.

(Legal) Manufacturer’s Name
(Legal) Manufacturer’s Address

Please submit an unsigned version of this Application in Word as well as a signed copy - either scanned/secured (pdf) copy.

Europe / N. America
NSAI
1 Swift Square,
Northwood,
Santry,
Dublin 9
Ireland
Phone : (01) 807 3929
Fax : (01) 807 3996
/ NSAI Inc.
402 Amherst Street
Nashua
NH 03063
USA
Phone : (603) 882 4412
Fax : (603) 882 1985

AD-25-26 Rev 1.1 / Page 1 of 13

PART 1 - GENERAL

Section / New Requirement / Y/N
or n/a / If “Yes”, how addressed / If “No”, not applicable justification/rationale
Art. 1
Sect. 2a / Is the product software intended to be used specifically for diagnostic &/or therapeutic purposes, intended to be used for the purpose of –
Diagnosis, prevention, monitoring, treatment etc.?
If so, is this product now covered as a medical device?
Art. 1
Sect 6 / Is the device intended to be used in accordance with both the Medical Devices Directive (MDD) and the Personal Protective Equipment (PPE) Directive?
If so, is Annex I of 89/686/EEC also met?
Art. 3 2nd para / Does the device also fall under the term “machinery” per Article 2(a) of 2006/42/EC?
If so, is Annex I of 2006/42/EC met where more specific that the Essential Requirements of the MDD?
Art. 12 / Does Article 12 apply?
(systems & procedure packs)
If so, is conformity assessment procedure Annex II or V (only) used?
Art. 14
Sect. 2 / Is the Manufacturer outside the EU?
If so, has a single Authorised Representative been designated in the EU?

Per Article 20, Section 2 Please note that the following information shall not be treated as confidential:

a)information on the registration of persons responsible for placing devices on the market in accordance with Article 14

b)information to users sent out by the manufacturer, Authorised Representative or distributor in relation to a measure according to Article 10(3)

c)information contained in certificates issued, modified, supplemented, suspended or withdrawn

PART 2 - Essential Requirements

E.R. / Additional/Revised Requirement / Y/N
Or n/a / If “Yes”, how addressed / If “No”, not applicable justification/rationale
1. / Has risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used been reduced as far as possible?
(design for patient safety)
Has consideration been given to the technical knowledge, experience, education and training & where applicable the medical and physical conditions of intended users?
(design for lay, professional, disabled or other users)
6a / Does demonstration of conformity with the essential requirements include a clinical evaluation in accordance with Annex X
7.1 / Has biophysical or modeling research been used in relation to chemical, physical &/or biological properties?
If so, has their validity been demonstrated beforehand?
7.5 / Has attention been given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I of 67/548/EEC (classification packaging & labeling of dangerous substances)?
Does the device or parts of the device administer &/or remove medicines, body liquids or other substances to/from the body?
Or does the device transport & store such body fluids or substances?
If so, do these devices contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I 67/548/EEC?
If so, are these devices labeled on the device itself &/or on the packaging for each unit, or where appropriate on the sales packaging, as a device containing phthalates?
Does the intended use of such devices include treatment of children or treatment of pregnant/nursing women?
If so, is there a specific justification for the use of these substances with regard to compliance with this particular essential requirement, within
- the technical documentation
- the IFU?
Is there information on residual risks for these patient groups, and if applicable, on appropriate precautionary measures?
12.1a / Does the device incorporate software or is it medical software?
If so, is the software validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification?
13.3b / Does the label bear the details strictly necessary for the user to identify the device and the contents of the packaging especially for the users?
13.3f / Is the device indicated for single use?
If so, is this indication consistent across the Community?
13.6h / If the device is for single use, does the IFU provide information on know characteristics and technical factors that could pose a risk if the device were to be re-used?
If no IFU is needed (ER 13.1), can the information be made available to the user upon request?
13.6q / Does the IFU have a date of issue or the revision?

Part 3 Conformity Assessment Annex II or V

Section / New Requirement / Y/N
or n/a / If “Yes”, how addressed / If “No”, not applicable justification/rationale
2, 2nd para / Does the Declaration of Conformity cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference?
3.1 / Do you undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X?
ANNEX II ONLY
3.2 / Please supply the corresponding documentation, data and records arising from the procedures for monitoring and verifying the design of the products
If this has already been supplied, please indicate the location of the information.
3.2b / Is the design, manufacture &/or final inspection and testing of the products, or elements thereof, carried out by a third party?
If so, please supply the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.
5.2 / Please supply pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable.
If this has already been supplied, please indicate the location of the information.
ANNEX V ONLY
3.2b / Is the manufacture &/or final inspection and testing of the products, or elements thereof, carried out by a third party?
If so, please supply the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party.
ANNEX II or V
6.1 (5.1) / Is the device implantable?
If so, are records maintained for a period ending at least 15 years after the last product has been manufactured?

Part 4 CLASSIFICATION Annex IX

Section / New Requirement / Y/N
or n/a / If “Yes”, how addressed / If “No”, not applicable justification/rationale
1.4 / Is the device stand alone software?
If so, it is considered as an active medical device
1.7 / Is the device used in the arcus aorta, aorta descendes to the bifurcation aortae?
If so, has the classification been reviewed, since these vessels are now considered part of the Central Circulatory System?
2.6 / Is the usage of the device discontinued in order for the device to be replaced immediately by the same or an identical device?
If so, this is considered an extension of the continuous use of the device. Does this have an impact on the classification, with respect to the duration of use?
Rule 6
1st indent / Is the surgically invasive device for transient use intended specifically to control, diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact with these parts of the body?
If so, then the devices are in Class III. Does this have an impact on the current classification?
Rule 6 3rd indent / Is the surgically invasive device for transient use intended specifically for use in direct contact with the central nervous system?
If so, then the devices are in Class III. Does this have an impact on the current classification?
Rule 7
1st indent / Is the surgically invasive device for short tem use intended specifically to control, diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact with these parts of the body?
If so, then the devices are in Class III. Does this have an impact on the current classification?
Rule 15 / Is the device intended specifically to be used for disinfecting invasive devices?
If so, then the devices are in Class IIb. Does this have an impact on the current classification?
Rule 16 / Is the device specifically intended for recording of X-ray diagnostic images? Note – the rule now includes all devices, not just “non-active” ones.
If so, then the devices are in Class IIa. Does this have an impact on the current classification?

Part 5 CLINICAL EVALUATION Annex X

Section / New Requirement / Y/N
or n/a / If “Yes”, how addressed / If “No”, not applicable justification/rationale
1.1 / Does the evaluation of clinical data (clinical evaluation) take account of any relevant harmonized standards?
Does the clinical evaluation follow a defined & methodologically sound procedure?
Is the clinical evaluation based on a critical evaluation of –
The relevant scientific literature OR
The results of all clinical investigations made OR
The combined clinical data from literature & investigations
If used, is the critical evaluation of relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device?
If using scientific literature, is there demonstration of equivalence of the device to the device to which the data relates AND
Does the data adequately demonstrate compliance with the relevant essential requirements?
1.1a / Is the device Class III or implantable?
If so, were clinical investigations performed?
If not, is there justification to rely on existing clinical data?
1.1b / Is the clinical evaluation & its outcome documented?
Is this documentation included &/or fully referenced in the technical documentation?
1.1c / Is the clinical evaluation and its documentation actively updated with data obtained from the post-market surveillance?
Is post-market clinical follow-up part of the post-market surveillance plan for the device?
If not, is this justified & documented?
1.1d / If demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, is there adequate justification for this exclusion?
Is this justification based on risk management output – considering :
The specifics of the device/body interaction
The clinical performances intended
The claims of the Manufacturer
If demonstration of conformity with essential requirements is by performance evaluation, bench testing and pre-clinical evaluation alone, is this substantiated?
2.3.5 / Clinical Investigations
Is there a requirement to ensure that all serious adverse events are fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed?

Manufacturer’s Additional Comments:

In signing this form, the manufacturer is

  • Declaring that the information in this form is correct;
  • Verifying that the additional requirements of the Directive 2007/47/EC have been applied in full and will continue to be implemented.

Signed on behalf of the Manufacturer: / Date:
Name (please print):
Position / Title:
Email:
Contact person
(if different to Manufacturer):
Phone:
Email:

NSAI Review

TO BE COMPLETED BY NSAI ONLY

Reviewer & date :

Items to be followed up :

Additional Review required : No Yes : If YES, then Scheduled for

If NO, please complete the following:

AAR, recommending change of Database to update to 93/42/EEC as amended by 2007/47/EC

Draft letter with contact details regarding approval of update

Update TRC – next meeting

Additional Comments :

AD-25-26 Rev 1.1 / Page 1 of 13