Annex II Templates

The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices

Annex II Templates

Single one-off payment £295

Buy now

Also included in our discount bundle offers

  1. Technical Documents Master / Full price £885 Discounted bundle price £595

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.

  1. 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.

  2. 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.

  3. 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.

  4. Quickly and easily produce important documents that are mandatory for EU MDR approval.

  5. No - following purchase, the templates are yours to keep without any additional payments.

  6. 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 document templates 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

  • 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
  • Also available to purchase in our bundle offers

Single one-off payment £295

Buy now

Bundle offers

We also offer reduced price bundles of related training courses and templates.

  1. Technical Documents Master

    Full price, bought separately £885

    Discounted bundle price £595

    Buy now

Prices shown exclude UK/EU VAT

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    Invoices can be found in your Settings > Billing section.

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