Notification of Changes

Customer number

Company

Street

Postal code, place

Concerned product / product group Registration number of concerned certificate

According to the certification contract between mdc and the company planned substantial changes are subject to notification. The following changes are planned or have been implemented:

Organizational changes: Change of legal form or name of the company Change of company address Change of organizational structure Change of proprietor Business units, subsidiaries or manufacturing sites to be added or deleted Change of number of employees since the last audit more than 25% (companies with more than 20 employees) Number of employees so far: , number of employees new: 5 or more employees (at companies with 20 or less employees) Number of employees so far: , number of employees new: Change of personal responsibilities (management, quality management representative)

Changes in the field of manufacturing and quality control: Change of manufacturing technology Change of sterilization procedure Change of special processes Change of test procedures

Changes regarding products: (only for proceedings in accordance with Directive 93/42/EEC and 98/79/EC): Change of critical suppliers (NBOG 2010-1*) Change of subcontractors New product or product group to be certified New product in already certified product group Cancellation of a product or a product group Change of intended use Change of use of the product/of user Change of classification of the product Change of performance characteristics and limitations Change of raw materials/components Change of accessories Change of stability/shelf-life/transport stability Change of power supply of product Change of CPU or other hardware Change of software / operating system / algorithms Change of labelling/instructions for use New information regarding risks in connection with the product Change regarding compliance with harmonized standards or essential requirements Change of technical file 160 101 /03

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Other changes:

Manufacturer’s estimation regarding importance of the change: (only for proceedings in accordance with Directive 93/42/EEC and 98/79/EC):

Substantial change (NBOG 2014-3*): yes no Risk analysis is concerned: yes no Compliance with essential requirements is concerned: yes no

Description of the change

Documentation of the change in the quality system / in the technical file: (list of documents and records)

Reason for the change:

Possible effects on the compliance with the Essential Requirements:

Date Name, Signature, Company stamp 160 101 /03

Assessment by mdc Is the change substantial? (NBOG 2014-3*) yes no

Justification for differing opinion on the assessment of the manufacturer

Essential actions: Feedback to the manufacturer Positive letter of confirmation (Examination within the framework of the next audit) Positive letter of confirmation (Examination within the framework of sampling review) Confirmation with further steps: Other:

Information of the audit team for the next audit Assessment by auditor/expert New certificate is necessary Amendment to the EC-design examination certificate is necessary Update sampling plan

Date Cipher, Signature project manager (mdc)

* NBOG BPG 2010-1: http://www.nbog.eu/resources/NBOG_BPG_2010_1.pdf ** NBOG BPG 2014-3 : http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf

160 101 /03