Be consistent, stay consistent
With increased market surveillance focusing on the compliance and quality of authorized representatives, it’s crucial to be well-prepared. Recently, a survey conducted by the Dutch competent authority revealed issues with every sampled authorized representative. A significant number lacked a proper mandate, while the majority failed to effectively manage client compliance. Similar surveillance efforts are planned across Europe, potentially making 2026 the ‘Year of the Authorized Representative’. Authorities will need to assess a substantial number of authorized representatives, prioritizing those who stand out for the wrong reasons. Avoid drawing unnecessary attention by ensuring all shared information is clear, accurate, and consistent. Utilizing high-quality, pre-tested templates can help achieve this consistency and project professionalism to authorities.
Support Your Clients
Entering the Union Market can be daunting for non-EU manufacturers. A competent authorized representative helps guide them through this process, beginning with setting the right expectations. It’s essential for an authorized representative to be firm with clients to ensure their compliance standards are adequate. This starts with an agreement outlining processes to thoroughly verify compliance. It continues with fair and effective compliance checks, extending beyond the acceptance of the mandate. Once the client starts placing devices on the market, the authorized representative plays an ongoing role in vigilance, post-market surveillance, and periodic compliance verification. Using a well-structured set of templates can streamline these processes, ensuring they are both efficient and consistent.
The templates
The template set comprises 28 forms, including five procedures. Some procedures are supplemented with work instructions to simplify complex tasks. Additionally, Article 10a templates are included to assist authorized representatives in cases where a manufacturer discontinues the supply of devices. While not strictly required, the set also includes a declaration of conformity template, which can be shared with clients as part of your service.
Obtaining the templates
The templates will be shared with the client, and any updates to the set will be provided for one year. This includes newly added forms. Additionally, there is an optional offer for implementation assistance at a reduced consulting rate.
- Full set of authorized representative templates: €1,950 (excluding VAT)
- Additional implementation support: €150 per hour (up to 4 hours, only time used to be invoiced)
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
