Bringing a medical device to market is a long and complex process. Understanding which regulatory authorities affect manufacturing, validation, verification, and other processes is the key to maintaining compliance and successfully gaining approval for your device. Learn more with this look at the global medical device regulatory authorities.
The Code of Federal Regulations Title 21 Part 820
In the United States, the Code of Federal Regulations (CFR) is a set of 50 titles that maintain general and permanent rules for the different departments and agencies of the federal government. Title 21 encompasses the rules of the Food and Drug Administration (FDA), including regulations for medical devices. Part 820 of this title addresses quality system regulations. This section consists of several subparts covering requirements, controls, monitoring, and more.
It is important to note that the FDA approved revisions to Part 820 in February of 2024. These updates, which go into effect in February 2026, better align FDA standards with the internationally recognized ISO 13485 Medical Device Quality System standard. The changes revolve around the two initial subparts of the regulation. In the opening “General Provisions” subpart, updates have been made to the sections discussing scope, definitions, incorporation by reference, and requirements for a quality management system.
Quality System Requirements
This second subpart of part 820 originally discussed quality system requirements, dictating that it is management’s responsibility to establish a quality policy and ensure all levels of the organization commit to that policy. Quality system requirements include rules about organization, management review, quality planning, system procedures, quality audits, and personnel education and training.
Revisions to this subpart change the title to “Supplemental Provisions” and create updated sections discussing control of records and device labeling and packaging controls.
Design Controls
Design controls ensure that the device meets specific requirements before heading to market. These controls include initial design and development planning, design input and output, review, verification, validation, design transfers and changes, and the maintenance of a design history file.
Document Controls
Document controls offer guidelines for the approval and distribution of all documentation as well as any document changes throughout the process. It also addresses considerations such as document availability, removal of obsolete documents, and records of document changes.
Purchasing Controls
Manufacturers must meet certain requirements when purchasing relevant products or services. This includes evaluating all suppliers, contractors, and consultants to ensure they meet necessary specifications. It also includes collecting and maintaining data about purchases, including data about purchase evaluations and quality requirements.
Identification and Traceability
Identification and traceability address the importance of clear and comprehensive device monitoring. Identification dictates that manufacturers must have procedures for identifying their products during all stages of development and distribution. Traceability states that manufacturers should establish procedures for identifying a device by unit, lot, or batch in order to take corrective action in the event of user injury.
Production and Process Controls
This subpart offers guidance for developing, conducting, controlling, and monitoring production processes. Process controls should include documented instructions, monitoring of process parameters, and compliance with specific regulatory standards or codes.
It covers factors such as:
- Production and process changes
- Environmental control
- Personnel
- Contamination control
- Buildings
- Equipment maintenance, inspection, and adjustment
- Manufacturing material
- Automated processes
This section also covers controls for process validation, as well as the inspection, measuring, testing, and calibration of equipment.
Acceptance Activities
Acceptance activities outline rules and acceptance status for device acceptance of incoming, in-process, and finished devices. Outlining these acceptance criteria ensures compliance and creates clear records throughout the process.
Nonconforming Product
This subpart discusses controls for products that don’t conform to specified requirements. This includes identification, documentation, evaluation, segregation, and disposition of these products.
Corrective and Preventive Action
Manufacturers need to have procedures that allow them to implement both corrective and preventive action. These procedures must include the following:
- Thorough process analysis
- Investigation of the cause of product or process nonconformities
- Identification, verification, and validation of corrective or preventative actions
- Recording and implementation of method changes as a result of corrective or preventative action
- Process of relaying quality issues to responsible parties to prevent further incident
- Submission of all relevant information to management for review
Labeling and Packaging Control
Labeling and packaging control provides rules for the integrity, inspection, storage, and operations of device labeling to prevent mix-ups and ensure quality control. It also states requirements for the location of a device control number.
Additionally, this subpart ensures packaging design, shipping containers, and other solutions adequately protect the medical device during processing, storage, handling, and distribution.
Handling, Storage, Distribution, and Installation
Handling requirements prevent damage, deterioration, contamination, and other issues during product handling. Storage requirements ensure manufacturers maintain adequate procedures for controlling, organizing, and monitoring safe product storage areas. Distribution covers procedures for controlling distribution, reviewing orders, addressing errors, and ending the distribution of expired or deteriorated devices. Installation requirements cover installation and inspection instructions and test procedures, as well as how to distribute device instructions and procedures.
Records
This subpart addresses the maintenance of required records. It details requirements for storage and availability, backup and other loss prevention procedures, confidentiality, retention periods, and exceptions.
Servicing
If servicing is a requirement, manufacturers must maintain clear instructions for the performance and verification of their servicing needs. In addition to this requirement, this subpart provides guidelines for analyzing and documenting service reports.
Statistical Techniques
This subpart addresses statistical techniques for achieving acceptability of process capability. Manufacturers must maintain procedures for identifying their valid statistical techniques. They must also base sampling plans on valid statistical rationale to ensure these methods are suitable.
Medical Device Regulation
Another global medical device regulatory authority to look at is the Medical Devices Regulation (2017/745/EU), or MDR. This is a European Union (EU) regulation that addresses medical device production and distribution for the European market. Below are a few of the main provisions it addresses.
Classification
The EU MDR defines different medical device classifications based on the device’s purpose and risk. These classifications are Class I, IIa, IIb, and III.
Notified Bodies
Notified bodies are independent parties that assess medium- and high-risk medical devices before market approval. The MDR presents rules for designating, organizing, and monitoring these bodies so that they meet a consistently high standard of quality throughout the EU.
Clinical Data
The MDR also specifies requirements for clinical data collection. This includes information on clinical investigations and trials and rules on informed consent. It also dictates that there will be a single coordinated assessment for clinical investigations that occur in multiple EU member states.
Obligations of Manufacturers
Manufacturers have a strict responsibility to monitor quality, performance, and safety of their medical devices. They must establish quality management systems and post-market surveillance systems, and they are liable for damages resulting from defective devices.
Traceability
The MDR introduces a traceability system that uses a unique device identifier to register devices, manufacturers, importers, and authorized representatives. This allows parties to take rapid corrective action in the event of a defective device or other problem.
Incident Reporting
Manufacturers must report serious incidents as well as ongoing trends in non-serious incidents. The MDR also states that member states must encourage and enable such incident reporting for healthcare professionals, users, and patients.
Market Surveillance
The MDR places the responsibility of keeping unsafe or non-compliant devices off the market on the relevant EU authorities. It is also up to these authorities to withdraw a device from the market if it is found to be unsafe for users.
Eudamed
The MDR also establishes the European database on medical devices (Eudamed). This is a centralized system that provides information on medical devices to economic operators, healthcare professionals, patients, and the general public in member states.
Medical Device Testing Done Right
There’s a lot to keep in mind when preparing your medical device for market approval. That’s why it helps to work with experts who are versed in the relevant regulatory authorities in your area. Visit Highpower Labs today to learn more about our medical device testing services and see how we can help prepare your device for market.