“How much is this going to cost?” It is the question every manufacturer asks in the first or second meeting. The honest answer is: more than you think, and it depends on several variables you do not fully control.
Here are the real ranges, item by item, for MDR Class IIa compliance of a device of standard size and complexity in an SME of 20 to 50 people that did not start from scratch.
The technical documentation: the most variable item
Clinical evaluation (CER + PMCF). Between 15,000 and 40,000 euros depending on the clinical complexity of the device, the quality of the data available in-house, and the number of references covered. A CER for a device with a solid clinical history and abundant literature costs less than a CER for an innovative device with no bibliographic precedent.
Risk management. Between 5,000 and 15,000 euros for ISO 14971:2019 compliance and writing the report. Variable depending on the complexity of the device and the state of the existing file.
Missing technical studies. Biocompatibility under ISO 10993: 10,000 to 30,000 euros depending on the number of tests required. Sterilisation validation: 15,000 to 40,000 euros. Performance testing: highly variable depending on the type of device.
Writing the complete file. Between 10,000 and 25,000 euros of consultant support for writing and structuring the complete file in accordance with Annex II.
The ISO 13485 QMS: the item that is often underestimated
If ISO 13485 certification does not yet exist or must be substantially reworked to cover the MDR requirements: 20,000 to 50,000 euros of support, plus the certification costs (5,000 to 12,000 euros for the certification audit by a certification body).
If ISO 13485 certification exists and is up to date: cost limited to bringing the few MDR-specific processes not yet covered into compliance.
The notified body: the most predictable item
Initial fees for the audit and review of a Class IIa file: 15,000 to 40,000 euros depending on the notified body and the number of devices reviewed. Annual surveillance fees: 5,000 to 15,000 euros per year.
The realistic total
For an SME that starts from an existing base (valid ISO 13485 certification, partial technical documentation under the directive) and brings a standard Class IIa device into compliance, the realistic total budget is between 60,000 and 120,000 euros over 18 to 24 months.
For an SME that starts from scratch on every front, or whose device has complex clinical characteristics, the budget can exceed 150,000 to 200,000 euros.
These are substantial investments. They correspond to access to a market of 450 million consumers with a certification valid for 5 years and renewable.