- Eliminate doubt and gain assurance when developing technical documents
- Full coverage of all principal documents that are unique to EU MDR Annex II
- Easy to complete using your existing product knowledge
- Save time and ensure first-pass regulatory approval
- Developed according to all relevant guidelines and Notified Body assessment schemes
EnableCE Build Annex II Templates
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices
Empowering you to build your technical document portfolio
- 21 fill-in templates
- Eliminate doubt and gain assurance when developing technical documents
- Full coverage of all principal documents that are unique to EU MDR Annex II
- Easy to complete using your existing product knowledge
- Save time and ensure first-pass regulatory approval
- Developed according to all relevant guidelines and Notified Body assessment schemes
In more detail
An extensive library of ready-to-use EU MDR Annex II technical document templates.
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It is designed for any member of a medical device company with responsibility for ensuring alignment with EU MDR requirements. It does not require specialist regulatory knowledge.
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Complete coverage of all principal Annex II requirements, including templates for; General device description & specification, Information to be supplied by the manufacturer, Design and manufacturing information, General Safety & Performance Requirements (GSPRs), Product verification and validation, and more.
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This package does not include templates for Risk Management, Clinical Evaluation or SSCP. All of these templates are available separately through EnableCE on our website.
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Quickly and easily produce important documents that are mandatory for EU MDR approval.
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No - following purchase, the templates are yours to keep without any additional payments.
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The templates open with standard Word Processing (e.g. Microsoft Word), Spreadsheet (e.g. Microsoft Excel) and PDF applications. They require no activation or access codes.
Download today
You can download and use your technical documents immediately after purchase.
Annex II Templates
- 21 fill-in templates
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices
Single one-off payment £295
Prices shown exclude UK/EU VAT
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For all purchases, you will receive a receipt by email confirming payment.
Templates & tools:
You will receive an email containing a link to download your files.Training courses:
You will go through the account set up process to access the training course platform.Training course + template package:
You will go through the account set up process to access the training course platform. Within one working day you will receive an email to download your template(s).
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