US FDA
Medical Devices in the United States are regulated by the FDA. The FDA categorizes medical devices and IVD devices into 3 classes. Class I are low risk, Class II are moderate risk, and Class III are high risk. Depending upon the risk level and the presences of substantially equivalent devices, companies are required to either maintain in-house document (generally Class I), submit a 510(k) (generally Class II), or submit a PMA (generally Class III). Once authorized to market your device, companies are required to register their facilities (fees are paid annually) and complete a product listing. From this stage forward, the organization is required to be in compliance with the FDA cGMP requirements (Part 820) for the lifetime of the product. The FDA conducts random audits of organizations.
Useful FDA Links
Useful FDA Links
- US FDA Medical Device Regulations - FDA CFR 21
- Part 820 - Good Manufacturing Practices
- Part 801 - Labeling
- Part 803 - Medical Device Reporting
- Part 806 - Recalls
- Part 830 - Unique Device Identification
- FDA Device Advice: How to Study and Market Your Device
- FDA Device Advice: Who Must Register
- FDA Guidance Documents
- FDA Small Business Designation
European Union (EU)
In the European Union, medical devices are regulated under one of three directives based upon the type of device: IVDD, MDD, or AIMDD. In May 2020 these directives are being replaced by the MDR and IVDR. The EU categories medical devices into Class I, IIa, IIb, and III based upon risks and a set of rule in the appendix of the applicable directive. To market a medical device in the EU, the device require to have a CE Mark and the device manufacturer compliant with ISO 13485. Class IIa, IIb, and III device manufacturers are required to be certified to ISO 13485 by a notified body (e.g. BSI Group, TUV SUD, SGS, etc.). Additionally, Class IIb is required to have the Technical File audited by a notified body and Class III devices are required to submit design dossiers. Once a CE Mark is obtained, your are ready to market your medical device. Keep in mind some countries in Europe require a separate country specific Establishment Registration.
If your organization does not have a physical presence in the EU, you will need to contract an European Authorized Representative.
Useful EU Links
If your organization does not have a physical presence in the EU, you will need to contract an European Authorized Representative.
Useful EU Links
- Medical Device Regulation(MDR) - 2017/745 (Replacing 93/42/EEC & 90/385/EEC in May 2020)
- In Vitro Diagnotic Medical Device (IVDR) - 2017/746 (Replacing 98/79/EC in May 2020)
- Medical Device Directive (MDD) - 93/42/EEC
- Active Implantable Medical Device Directive (AIMDD) - 90/385/EEC
- In Vitro Diagnotic Devices (IVDD) - 98/79/EC
- EU MEDDEV Guidance Documents
- International Medical Device Regulators Form
health Canada
Canada regulates medical devices under the CMDR (SOR/98-282). Canada categorizes medical devices into Class I, II, III, and IV based upon risk and establish rules in the CMDR. In Canada, manufacturers of Class I medical devices do not have quality system requirements. Manufacturers of Class II, III, and IV medical devices are required to be certified to ISO 13485. Canada is looking to utilize the Medical Device Single Audit Program (MDSAP) to replace the CMDCAS mark on the ISO 13485 certificate, either way the requirements ISO 13485 are still audited. Once a manufacturer has obtained proper certification, they must submit an application for a Medical Device License (MDL). The information required to be included in the application depends upon Class and varies from simple labeling information to a complete Technical File to a Design Dossier. Once the MDL is obtained, the organization must complete a Manufacturer's Registration and you are ready to market your medical device.
Useful Canadian Links
Useful Canadian Links