The 9 steps to get medical certification for your biomedical product
from drugs, to device, AI, and robotics
“Brain implant as a rainbow” from StableDiffusion, image of the author
This week Paradromics gets one step closer to FDA approval for its brain implant. While it is obvious why an invasive device touching the brain requires certification, it is not clear to many people that even other unsuspected devices (as a thermometer) also requires certifications. With the plethora of tools AI based diagnostic in those years, validations are required, also because what is a hype on social media, news and research not necessarily it is translated overnight in clinics.
Medical devices are not like any other product, most often they require specific certification to be accredited in the market. Although, in some cases devices without certification are used upon clear disclaimer and agreement of the lack of certification.
For a young startup with limited funding, this might be a temporary solution. They launch “a research product” which is used nevertheless, and in the meantime they start the process of proper certification. Obviously the lack of certification, can reduce drastically the number of investors, clinical partners and customers, but it can be a start.
The need of certification is given by the fact that some of these devices will be used to assess vital signals or perform life-threatening (like a peacemaker), therefore a certification is necessary before is trusted by medical personnel worldwide.
First of all what Products Are Considered Medical Devices?
In general, medical items can be divided into three groups based on the degree of danger associated: from low-risk equipment like medical thermometers, disposable gloves, or tongue depressors to high-risk implants like pacemakers that are necessary to maintain life. It is mandatory that any medical device being sold in the European Union bears the CE Mark and FDA in America. Some African and Asian country will directly grant a local certificate if one of those certificate already exists. UK might be a more complicated cases as they need to revalidate the CE mark according to their legislation which is more complex than those of average African countries.
For the CE certification, the European Commission Regulation (EU) No. 2017/745 has to be followed for medical device, the No. 2017/746 for in-vitro diagnostic devices, Medicinal Products that include a Medical Device (combination products e.g. medicine and device) Directive 2001/83/EC.
First there is the need to determine the classification of the device: Class I (self-certified), Class I (sterile, measuring, or reusable surgical instrument), Class IIa, Class IIb, or Class III. The EN ISO 13485 standard is typically used by businesses to achieve compliance. Plans for Clinical Evaluation, Post-Market Surveillance, and Post-Market Clinical Follow-Up are required to be included in the QMS. Additionally, it's crucial to organize for Notified Body audits with suppliers. Software and robotics related to existing accredited devices do not automatically gain certification, and further certification might be required.
It is crucial to remember that depending on the nation or region you are in, the particular criteria and procedures may change. However, I can provide below a general description of the procedures needed to receive such a certificate:
1. Research the Rules: Become familiar with the rules and specifications that apply to biological certificates in your jurisdiction. These rules might cover biomedical device-specific safety requirements, documentation requirements, testing protocols, and quality control measures.
2. Select Certification Class: Recognize your nation's system for classifying biological credentials. According to the risk posed by the device, classifications are often divided into groups like Class 1, Class 2a, Class 2b, and Class 3. Decide that a Class 2b certificate is what you require.
3. compile Technical Documentation: Compile and compile your biomedical device's technical documentation. This normally consists of test results, design specifications, manufacturing procedures, risk analyses, and clinical evaluations. Make sure your documentation complies with the precise specifications listed by the regulatory authority.
4.Test and evaluate your biomedical device: Take part in testing and assessment procedures. This could entail doing laboratory testing, performance analyses, and safety evaluations. You could be required by some nations to use an authorized testing laboratory for certain tests.
5. Implement Quality Management System: To guarantee the consistency and quality of your biomedical equipment, establish a strong quality management system (QMS). Follow international quality standards like ISO 13485 to show that you are in compliance with all legal obligations. Processes including design control, risk management, traceability, and post-market monitoring may be included.
6. Technical File Compilation: Create a thorough Technical File by compiling all the pertinent test results, technical reports, and quality management system documentation. The Technical File is often sent to the regulatory body as part of the application process and serves as proof of compliance with regulatory requirements.
7.Application Submission: Fill out the application form offered by the regulating body and send it in with the Technical File and any other necessary paperwork. Pay any associated fees that may be necessary.
8 .Regulatory Review: Your application, technical materials, and test results will be examined by the regulatory body. Throughout this procedure, they could carry out on-site inspections or compel further data. Any questions or requests from the regulatory body must be answered quickly and completely.
9. Issuance of Certification: You will be given your biomedical certificate if your application is accepted and your gadget satisfies the relevant criteria. The class of certification as well as any restrictions or conditions imposed by the regulatory authority—will be specified in the certificate.
Resources
FDA website:
Development & Approval Process | Drugs | FDA
European Medicine Agency