Frequently Asked Questions

Short answer: from about €100.000 for a basic medical device up to several million for an advanced medical device (about €500.000 for implants).
Long answer: that depends on several factors: the type of device, what data is already available for example if we can use already established validations (BAAT has several for you to use), which market(s) you want to get approval for, how much risk you are willing to take, what lead time until market approval you have in mind, experience in medical product development….

Generally you can say, that there are three major pillars that determine a project: Budget, Quality and Lead-time. Quality is mostly dictated by the Medical Regulations which means that you have 2 pillars left to play with. If you aim to shorten your lead-time to get market approval in the fastest way ever possible, the budget goes up.

What will this investment bring you and your customers?
And what will be the return on investment for you?

About 1.5 years on average until submission at the competent authority. The shortest lead-time that we have accomplished for developing 7 spinal implants from concept to obtaining FDA approval was 10 months. For CE, the review time at a Notified Body generally takes longer when compared to the review time of the FDA, especially now with the MDR (the new medical device regulations). For an explanation on why this review time is increased, see our explanation at the next question.

You need to guarantee that your device is safe and effective for its whole lifetime. With device we mean all its aspects that also includes e.g.: tray, packaging, labels, IFU, surgical technique, instrumentation, accessories, manufacturing processes, end-user training and transport to get it to the end-user.

Besides Engineering your device (Engineering is usually the easy part), you need:

• A Medical Device Development Process to organize your medical device development in the most efficient way.
• A Notified Body (NB) if you aim for CE approval. Getting a NB became quite tricky now with the MDR; the new medical device regulations. Only a few NBs are MDR approved and those that are generally don’t take any new customers or they have a very long queue for review times to obtain market approval.
• To comply with the General Safety and Performance Requirements (GSPR).
• A Declaration of Conformity (DOC).
• Risk Management (to adress and mitigate risks related to your Design, Production and Application).
• Validations (Biological, Sterilization, Transport, Shelf Life, Dose Mapping, Mechanical, Usability, Clinical, Manufacturing, MRI Safety, Reprocessing) depending on what is needed for your medical device and required your market. TIP: make use of our knowledge on how to smartly combine validations for different markets so you need to perform these validations only once instead of multiple times for different markets.
• End User Information (Surgical Technique, Labels, IFU, user training, (dis)assembly instructions, reprocessing instructions etc.)
• A Technical Dossier (TD, also called Technical File: TF) or FDA file (e.g. 510(k) file/ De Novo/ Premarket Approval) that you can submit at a competent authority such as the Notified Body or FDA, respectively.
• A Device Master Record (DMR, also called Device Manufacturing Record), which is the recipe on how to make your device.
• A Quality Management System (QMS) conform ISO 13485 !with the correct scope! (for CE) or 21 CFR 820 (for FDA)
• A system to handle your product responsibility after market approval: Operations and Legal Manufacturing for Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), complaints, trace your devices (ERP system), audits of approved suppliers, product insurance, stock management, order processing, inspection of incoming goods, adverse effects handling, update Risk Management when new regulations arise, maintain your warehousing, keep your certifications up to date, handle regular audits of the competent authority.

This depends on the classification of your device and if there are already similar devices with adequate data on the market that you target for. For implants and class III devices you will have to do a premarket clinical study unless:

• You develop a next generation, you are the manufacturer of this first generation, you are comparable to this first generation on several aspects (Mechanical/ Technological/ Biological/ Clinical) and you have adequate clinical data of this first generation.
• You are equivalent to a competitor device, you have full acces to the Technical File of this device (with a contract between manufacturers as proof) and you have adequate clinical data of this competitor device.
• Your device is one of the exemption devices explicitly mentioned in the MDR (such as dental fillings, staples, screws, wedges etc.)

If you need to do a pre-market clinical study, on average you need to account for €10.000 per patient and about 40 patients per study. This number can vary and depends mostly on the ‘to be tested’ outcome variable(s). To calculate the exact number we would perform a Power Calculation so you know how many patients should be included in this premarket clinical study.

What would you do if you knew the most efficient regulatory route to get market approval for your medical device?