The Tried and Tested AR Templates
Finally, a complete system for EU authorised representatives to work with confidence, and without guesswork.
26 battle-tested templates built to help you protect your clients, cover your business risks, and sleep at night. Used by high-performing authorised representatives across the EU. Created by a former senior inspector with 25+ years in regulatory affairs.
Covering all functions and roles of the authorised representative, these templates provide a practical cover of all the responsibilities of the authorised representative. They cover all regulatory processes of the authorised representative; from onboarding, via document control, vigilance, and continued compliance, to termination. Increase your confidence when the authorities check you out.
Does this sound familiar?
- A new client wants you to represent their 250+ devices, and they want the mandate signed yesterday
- An inspector makes you aware of a systemic error affecting all your clients that could potentially lead to a huge fine
- You find out after an incident that the device was not in your mandate
- A patient files a liability claim for a failing device that has your name on its label
What if you could proactively serve your clients?
- What if those issues would never happen again?
- What if your clients stopped discussing fees and started valuing your services?
- What if your onboarding process revealed risks before they became problems?
- What if your technical documentation reviews became fast, effective, and structured?
What clients say:
“I didn’t realise there were so many aspects to cover for an authorised representative.” Steven, Ireland
Be compliant, consistent, and clear
The Tried and Tested AR Templates cover:
- Complete documentation for every major authorised representative activity
- Dovetailing procedures, forms, and work instructions
- A mandate that covers all essential items of Article 11
- A separate agreement that respects your commercial interests
- The full process from onboarding, continued compliance, vigilance, and termination
These tools help you build a service your clients can trust and the authorities respect.
Want to try before you commit?
Start with the vigilance module for free (5 templates, worth € 375), and get instant access. Only if you want to use the full set of documents will you be charged. Most authorised representatives who try this first module sign up for the full package shortly after. Send an email to ronald@boumansconsulting.com
What you get with the Tried and Tested AR Templates set:
- 9* templates for onboarding of new clients and devices
- 5 Technical Documentation Doc review templates
- 4 Vigilance templates – specific for the authorised representative
- 5* templates involving the termination of the mandate
- 2 templates to monitor continued compliance
- 2 Article 10a templates
- Up to 4 hours of implementation help (optional) – only charged when used
These modules consist of procedures, forms and work instructions.
* One template is shared between the set for onboarding and termination
What clients say:
“The level of detail in these templates is mind-boggling.” Juliane, Germany.
You still have doubts?
Book a free 30-minute call to discuss how this toolkit may support your operations and address your concerns. Send an email to ronald@boumansconsulting.com
Meet your regulatory compliance expert: Ronald Boumans
When working as a senior inspector for the Competent Authority of the Netherlands (2002-2013), I was the gatekeeper for the Union Market for medical devices. I later joined the largest independent authorised representative in the world, Emergo. There, I helped shape the service and prepare for the new level of scrutiny under the Regulations.
The Tried and Tested AR Templates are exactly what they claim to be: tried and tested. This is experience converted into tools, so you don’t have to learn compliance the hard way. Become the gatekeeper the authorities want you to be.
What clients say:
“To all my questions, I got clear and useful answers, often in minutes.” Aurelie, France.
The practical details
- Suitable for authorised representatives working with multiple manufacturers
- Includes 26 templates organised in 6 modules
- The modules consist of procedures, forms, and work instructions
- This set of templates covers all requirements and responsibilities of the authorised representative
- Price for the complete set of templates: € 1950 excluding VAT (to order: ronald@boumansconsulting.com)
- Try the Vigilance Module free (worth € 375) and decide later (to order: ronald@boumansconsulting.com)
- Order this set of templates and get the PRRC training for € 169 instead of € 245 (to order: ronald@boumansconsulting.com)
- Price for four optional hours for implementation support, only to be charged when used: € 150 per hour (instead of € 275), excluding VAT* (to order: ronald@boumansconsulting.com)
* So far, none of the authorised representatives using this implementation support have used all four hours
The Tried and Tested AR Templates create structure, confidence, and compliance. Deliver your service like a professional — and never second-guess your process again.
For more information about the templates, assistance with implementation, or additional staff training, please contact us at: Ronald@boumansconsulting.com.
Available templates
- Onboarding
1.1. Onboarding procedure
1.2. Client Onboarding Form
1.3. Documentation Request Form
1.4. Article 12 Tri-Party Agreement Form
1.5. MDR Summary Transition Plan Form
1.6. IVDR Summary Transition Plan Form
1.7. AR Mandate Template
1.8. AR Agreement Template
1.9. Declaration of Conformity template - TD Review procedure
2.1. Doc review procedure
2.2. TF Checklist MDR
2.3. TF Checklist legacy MD
2.4. TF Checklist IVDR
2.5. TF Checklist legacy IVD - Vigilance
3.1. Vigilance procedure
3.2. Vigilance Case Tracking Form
3.3. Vigilance table
3.4. Work instructions authorized representative vigilance procedure - Termination
4.1. Mandate termination procedure
4.2. Article 12 Tri-Party Agreement Form
4.3. Termination letter template Competent Authority
4.4. Termination letter template notified body
4.5. Termination letter template manufacturer - Ongoing compliance
5.1. Request ongoing compliance
5.2. Checklist periodic compliance verification - Article 10a
6.1. Article 10a procedure
6.2. Article 10a checklist
