/ REQUEST FOR SERVICES
In Vitro Diagnostic Medical DevicesDirective (98/79/EC) and ISO 13485:2003
Please complete the form in full and return it to us, so that we can provide you with an accurate quotation for the services you require.
The Guidance Notesbelow clarify what information we require in the various sections of the form.
SECTION A
We require full details of the Company placing the product on the market, sites, activities, employees and contact details.
SECTION B
We need you to tell us what services you require and check the option you require.
  • Our pre assessment (gap analysis) visit is an optionthat we offer to help you review your readiness for assessment and to give you an early indication of any issues.

  • Quality system certification is the formal two-stage certification process against the directive and standards that you require.

You must define the scope of approval that applies to the specific activities controlled by your quality management system. The layout below may be used as a guide to write your approval scope:
MAIN ACTIVITY / SERVICEPRODUCTS REQUIRING CERTIFICATION
e.g., Design, manufacturee.g., HIV, HBV, HCV Assays, self test devices, etc.
You must identify the conformity assessment route that you require for In Vitro Diagnostic Medical Devices Directive - 98/79/EC and indicate this on the form.
SECTION C
We require details of any current management system or regulatory approvals that you hold, and also copies of all certificates. Certificates can be e-mailed with the form, attached as PDFs.
SECTION D
We need you to provide details of all the product names that you require Notified Body services for, including the description and classification.
We require specific information about your products and the description is the intended use of the IVD device including the condition analyte or disease marker that is being assessed and the type of technology used (for example, immunoassay or PCR).
Any product brochures/literature, or a web link where we can find the information would be useful. Please note that products classified as Annex II List A products under the IVD Directive will require a design dossier review and the establishment of batch verification for lot release.
If your products are being placed on the market as Own Brand Labelled Products, we will need you to include copies of the approval of conformity certificates for the original manufacturer. An Own Brand labeller (Overlabeller) is an organisation taking the regulatory responsibility of a manufacturer by placing such devices on the market for the same intended use under their own name.
SECTION E
If you have any sub-contractors who perform critical activities for you, you need to provide us with the details, for example, they manufacture critical components on your behalf, lyophilise products, etc.
SECTION F
Please provide details of the language of your management system, so that we can define any need for specialist resource. If based outside the EU, we need details of your Authorised Representative.
The more details we have, the more accurately we can assess your needs and meet your requirements.

SECTION A - Information about your company

Company name:
Main contact name:
Position in company:
Phone number: / Mobile number
Email:
Company Reg’n No:

Main site

Site address:
City / country:
Post Code: / Number of employees:
Activities on site:

Other sites (if your quality management system includes more sites, please list them here)

Site location: / Activities on site: / Number of employees:

If there are further sites, please provide the same information as above on an additional sheet.

SECTION B - Services You Require from LRQA

Pre-assessment visit

We can provide a gap analysis

to review your readiness for compliance.

Quality System Certification

Assessment standardsISO 9001:2008ISO 13485:2003

(Please check boxes as required)

Scope of Approval

Scope:

IVD Directive (98/79/EC) - CE Marking

Please indicate which conformity assessment route you require: (check one box only)

ANNEX III(Design Examination)Route for Self-Test devices only

ANNEX IV(Full Quality Assurance)

ANNEX VII(Production Quality Assurance)Only applicable with existing EC Type Certificate

SECTION C - Existing Approvals held by your company

Do you have a current certificate for any of the following:

ISO 9001:2008

ISO 13485:2003

IVD Directive (98/79/EEC) Approval & Annex

Please check the boxes that apply

Please provide details for all existing approvals:

Who issued the Certificate?
What is the Scope of Approval?
Date of last audit?
Expiry date of approval?

Do you wish LRQA to take over these approvals?YESNO

Certificates attachedYES

SECTION D - Information about your products

Please complete the following table with the specific information about your products.

Description is the intended use of the IVD device including the condition, analyte or diseasemarker that is being assessed and the type of technology used(for example, immunoassay or PCR).

Products requiring CE Marking

Product Type / Description of assay/device / Classification
List A, List B / Self-test

Are any of these products being placed on the market as ‘Own Brand Labelled’ products?

YESNO

If ‘Yes’, please provide a copy of the approval of conformity certificate issued to original manufacturer

SECTION E - Sub-contractor information

Do you have any sub-contractors who perform significant processes for you?

YESNO

(e.g., manufacture critical components on your behalf, sterilise or lyophilise products?)

If ‘Yes’, then please provide details:

Name and address:
Activity performed:
Details of any approvals:

Please continue on a separate sheet as necessary - attach copies of any relevant certificates

SECTION F - Additional information

What language is your quality system written in?

Note: LRQA requires product technical files or design dossiers to be submitted in English

If you operate outside of the EU, please provide details of your Authorised Representative?

Name:
Address:
Post code: / Country:

When do you anticipate that your company will be ready for assessment?

Once completed, please return all forms to us by one of the following methods: (E-mail preferred)

By e-mail: /
By post: / Lloyd's Register Quality Assurance Ltd
(Sales & Marketing)
Hiramford
MiddlemarchOfficeVillage
Siskin Drive
Coventry
CV3 4FJ
United Kingdom
By fax: / +44 (0)24 7630 2662
MSBSF41940Page 1 of 4Revision 3,27 May 2014