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Come stimare i costi per la certificazione MDR con TÜV RHEINLAND ITALIA?

TRI (TÜV RHEINLAND ITALIA) riporta di seguito l‘elenco dei costi applicati per le principali attività di valutazione della conformità secondo MDR (Medical Devices Regulation).

Il preventivo complessivo, correlato alle tariffe sotto riportate, potrà variare per i singoli dispositivi a causa di fattori non considerati nell‘elenco delle tariffe standard, come la complessità del dispositivo e della documentazione tecnica, il volume, la qualità e la completezza della documentazione tecnica, il numero di non conformità sollevate e i cicli di revisione necessari.

Type of Fee Fee in local currency Factors influencing the calculation of fee charged Fee range(min-max)
Administrative charges
  • Application fee
Flat € 1.450,00Complexity of request / Criticality of the product≥ € 1.450,00
  • Administrative fee related to changes
Flat € 350,00Complexity of request≥ € 350,00
  • Certificate issue fee
Flat € 1.100,00 Criticality of the product≥ € 1.100,00
  • Annual certificate maintenance fee (provide details which activities covered)
Flat € 600,00Criticality of the product≥ € 600,00
  • Regulatory Statement
Flat € 500,00Complexity of request≥ € 500,00
  • Travel timecosts (including motorway tolls)
Flat € 0,95Location of manufacturer≥ € 0,95/km
  • Travel timecosts (excluding expenses such as hotel costs)
Hourly€ 125,00Location of manufacturer€ 125,00/hour
€ 150,00/hour
Auditing (Fees exclude travel time and expenses)
  • Audit (Certification; Recertification; Surveillance; Subcontractor/Supplier)
Daily€ 1.840,00Number of FTEs; number
of sites; factors for audit
increases/reductions;
planning and reporting		€ 1.920,00
(0,5-24 days)
  • Unannounced Audit
Flat € 4.800,00Number of assessors on site≥ € 4.800,00
Product testing
  • Laboratory testing (including preparation and reporting but excluding expenditures incurred for external tests)
Hourly€ 200,00 Complexity of request ≥ € 200,00
Documentation Review
  • Technical documentation assessment
Daily€ 2.320,00Complexity of request / Criticality of the product€ 2.320,00 (3-15 days)
  • Technical documentation assessment - class III
Daily€ 2.720,00Complexity of request / Criticality of the product€ 2.720,00 (7,5-20 days)
  • Clinical evaluation report assessment (CEAR)
Daily€ 1.000,00Complexity of request / Criticality of the product€ 1.000,00 (1-3 days)
  • Expert panel consultation
Flat € 600,00Complexity of request / Criticality of the product≥ € 600,00
  • Validation of the Summary of Safety and Clinical Performance (SSCP)
Daily€ 2.320,00Complexity of request / Criticality of the product€ 2.320,00 (1-3 days)
  • Validation of the Summary of Safety and Clinical Performance (SSCP) – class III
Daily€ 2.720,00Complexity of request /Criticality of the product€ 2.720,00 (1-3 days)
  • Evaluation/review of the Periodic Safety Update Report (PSUR)
Daily€ 2.320,00Complexity of request / Criticality of the product€ 2.320,00 (1-3 days)
  • Evaluation/review of the Periodic Safety Update Report (PSUR) - class III
Daily€ 2.720,00Complexity of request / Criticality of the product€ 2.720,00 (1-3 days)
  • Assessment of changes
Hourly€ 240,00Type of changes/ Complexity of request / Criticality of the product€ 240,00-340,00
(4h – 5 days)
Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC TRI, in its ongoing commitment to support Small and Medium-sized Enterprises (SMEs), has introduced a series of financial benefits to facilitate access to its services. These measures are designed to ease the immediate financial burden on SMEs:
  • Favourable payment methods
    No Advance Payment Required. By confirming the order of TRI services, companies are not required to make any economic down payment. This approach has been taken to ensure that companies can plan and manage their financial resources without the pressure of initial charges.
  • Post-Invoicing
    The activities provided by TRI will only be invoiced after they have been provided. This means that companies will be able to benefit from the services before having to make any payments, allowing for better cash flow management.
  • Visibility through CERTIPEDIA platform
    The certification mark, linked for free to the CERTIPEDIA platform ( www.certipedia.com ), provides:
    • verification of certificate authenticity, as customers can quickly and easily verify the authenticity of certificates directly on the TÜV Rheinland website
    • support during tenders, border inspections and customs operations; visible certification status on Certipedia reinforces confidence in your products at critical times
    • simplified registration of medical devices, as the Certipedia link can be shared with the relevant authorities, facilitating the registration process
    • an advantage to show your commitment to the market.
The payment conditions described above are particularly advantageous for medical device manufacturers, who will benefit from targeted financial support and greater flexibility in managing their operational and production needs.
The financial facilities offered by TRI are a significant opportunity for companies aiming to improve their business processes and to invest more confidently in their future development.
In addition, these benefits are accompanied by a customisation of the duration of the audit activities conducted at the manufacturer's premises, which is worked out according to the size of the business entity, measured by the number of employees, thus guaranteeing a proportional approach adapted to the real business size of the manufacturer.
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