Annex II Templates

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

Single one-off payment £295

Empowering you to build your technical document portfolio

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

An extensive library of ready-to-use EU MDR Annex II technical document templates.

Who is this tool for?

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.
What document templates are provided?

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.
What templates are not provided?

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.
What will it enable me to do?

Quickly and easily produce important documents that are mandatory for EU MDR approval.
Are there any recurring payments?

No - following purchase, the templates are yours to keep without any additional payments.
What are the file formats?

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.

You can download and use your document templates immediately after purchase.

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 in our bundle offers

Single one-off payment £295

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

Prices shown exclude UK/EU VAT

What happens after I've paid?

After payment you will get access to our Resources platform where all your purchases are stored.

Invoices can be found in your Settings > Billing section.