The proposed act introduces strict standardization in four critical areas: quotations, timelines, interruptions, and re-certification.

1. Standardization of Quotations and Costs

To eliminate the “black box” of certification costs, the draft requires Notified Bodies to implement documented procedures for issuing quotations.

• Mandatory Information: Manufacturers must provide specific data to receive a quote, including the precise number of employees, annual turnover (to determine SME status), details on all manufacturing sites, and a clear description of the device and its intended purpose.
  
  
• Transparent Breakdown: The quotation must detail the estimated overall costs, separating fees for QMS assessments, technical documentation reviews, and surveillance activities. Crucially, travel and accommodation costs must be estimated separately and cannot be hidden within hourly rates.
  
  
• Cost Management: If costs exceed the initial estimate, the Notified Body must inform the manufacturer in a timely manner and provide a justification for the increase.

2. Maximum Timelines (“Speed Limits”)

For the first time, the Commission is proposing binding maximum timelines for Notified Bodies to complete specific phases of the conformity assessment:

• Contractual Phase: 30 days to review the application and sign the contract.
  
  
• QMS Auditing: 120 days from the start of the audit program to the final review.
  
  
• Product Verification: 90 days for the assessment of technical documentation.
  
  
• Certification Decision: 15 days to issue the certificate following the completion of reviews.

The draft also encourages efficiency by stating that QMS auditing and product verification should be conducted in parallel whenever possible.

3. Rules for “Stopping the Clock”

While Notified Bodies retain the right to interrupt timelines to request additional information or address non-compliances, the draft imposes strict caps on these interruptions to prevent indefinite delays:

• Application Review: Maximum 1 interruption.
  
  
• QMS Auditing: Maximum 3 interruptions.
  
  
• Product Verification: Maximum 3 interruptions.
  
  
• Change Assessment: Maximum 4 interruptions.

Interruptions due to external dependencies (e.g., pending opinions from expert panels or the EMA) do not count toward these limits.

4. Streamlined Re-certification

The draft explicitly prohibits Notified Bodies from repeating the full assessment performed during the initial certification. Re-certification reviews must be targeted, focusing strictly on:

• Changes to the device or its intended purpose.
  
  
• New data from Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR).
  
  
• Updates to the risk management file and compliance with the current “state of the art”.

Furthermore, Notified Bodies must proactively inform manufacturers that their certificates are expiring at least one year before the expiry date.

5. Transparency and Accountability

To foster competition and transparency, Notified Bodies will be required to publish an annual report on their website. This report must disclose key performance metrics, including:

• Timelines: Minimum, maximum, and median duration of conformity assessments.
  
  
• Costs: Minimum, maximum, and median total costs, including the percentage of “extra costs” not included in initial quotes.

Transitional Provisions

It is important to note that these new rules will not apply retroactively to all files immediately.

• Timelines and Interruptions: These rules will not apply to conformity assessments where a written agreement was signed before the regulation’s date of application (3 months after entry into force).
  
  
• Re-certification: The new streamlined re-certification rules will not apply to certificates expiring within approximately 18 months of the regulation’s entry into force.