Regulatory Affairs Training Notes

Regulatory Affairs Team: Roles and Responsibilities

  • The goal of this training is to understand the roles and responsibilities of the regulatory affairs team, as well as various certificates and their purposes.
  • Regulatory affairs functions are part of the quality services department, led by Andre Essen.
  • The quality services department reports to operations, led by COO Robert Weisman.

Leadership and Key Personnel

  • Andre Essen and Roman Eicher serve as group leads and Persons Responsible for Regulatory Compliance (PRRC).
  • Stella Oberlin and Roman Eicher work in regulatory affairs within the Product Quality Department.
  • The department manages various topics beyond regulatory affairs.

Regulatory Affairs Processes

  • Several Management Handbook processes fall under regulatory affairs.
  • The main process is "Regulatory Affairs," with subprocesses including:
    • Technical file product registration.
    • Product registrations: Defines how NDD products are registered worldwide.
    • UDI Management: Unique Device Identifier required for traceability, to localize devices in specific countries.
    • Clinical evaluation: NDD devices have a clinical benefit, and evidence is provided in the clinical evaluation.
    • Post-market surveillance: Regular overview of products in the market and competitor devices compiled into a report after product launch.

Role in Product Development

  • At the beginning of a project, regulatory affairs defines applicable standards, laws, and regulations based on target markets and intended use.
  • Intended use and target markets define requirements for processes. For example, if the USA is a target market, compliance with 21 CFR Part 820 is required.

Responsibilities After Product Development

  • After product development, regulatory affairs proceeds with initial product registration. The EU and USA are typically the first markets.
  • Regulatory affairs assesses changes and their impact on product registrations, including modifications or new registrations as part of change management.
  • An example of a typical change is the end-of-life of components and their replacements.

Post-Market Responsibilities

  • After initial product registration, the regulatory affairs team handles registrations in additional markets, defined with the sales team.
  • This includes reviewing promotional materials.
  • Regulatory Affairs maintains a database in confluence with country-specific information, including laws and guidances.
  • Besides product registrations, some countries require specific product-related certifications.

Definition of a Medical Device

  • According to the Medical Device Regulation (MDR), a medical device is:
    • Any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used alone or in combination for human beings for one or more specific medical purposes.
  • At NDD, almost all products are medical devices, including the NDD cloud or calibration check adapters.

Medical Systems

  • In The EU, a medical system is defined as medical devices and other devices with a CE mark.
  • Example: EZ on PC, which consists of the TruFlo sensor, EZ1 Connect software, and a nose clip.

Characteristics and Risk Classification

  • A medical device is characterized by its intended use, which defines its risk classification.
  • A risk-based approach is applied worldwide, but classification systems differ.
  • In the EU, the four classes are I, IIa, IIb, and III.
  • NDD spirometers and lung function devices are classified as Class IIa medical devices.
  • The EZ1 flow tube and Spirec are also classified as Class IIa medical devices.
  • The EZ1 filters, baryettes, and filter adapters are classified as Class I.

Safety and Effectiveness

  • Safety and effectiveness need to be proven for a medical device.
  • For NDD devices, this mainly includes electrical safety and proven clinical effectiveness.
  • NDD devices do not make a diagnosis; they only provide a measurement result. Interpretation is required by a health professional.

Instruction for Use (IFU)

  • An important document for a medical device is the instruction for use (IFU).
  • Product risk management defines part of the IFU content, such as risk mitigations, cautions, and warnings.
  • The extent and content of product documentation are predefined by health authorities and may differ (e.g., China).

Product Registration in the EU

  • Prerequisites:
    • Implementation of a quality management system according to IS−13485IS-13485.
    • At NDD, the Management Handbook covers the main requirements of IS−13485IS-13485.
    • Audited and certified yearly through a notified body (equals to the Ministry of Health).
    • Compilation of technical documentation for a specific product or product family.
  • Depending on risk classification, the technical file needs review for Class IIa or higher products are handled and approved through the notified body.
  • For Class I products, no involvement of the notified body is needed.
  • Once the technical file is approved, the Declaration of Conformity (DOC) can be signed by the manufacturer, and the CE mark, including the notified body number for Class IIa, can be affixed.
  • If these steps are completed, the medical device can be marketed in the EU.

Declarations of Conformity (DOC)

  • Examples of DOCs for Class I and Class IIa products:
    • Class IIa products list the notified body and reference the product certificate issued by TUVSUD.
    • Class I products: The manufacturer declares conformity without notified body involvement.
  • By signing the DOC, the manufacturer declares that the listed device conforms with applicable MDR requirements.

EC Certificate

  • The EC certificate is issued by the notified body per device group (e.g., E121501 for spirometry instruments).
  • New spirometry devices fall under this group.
  • Developing additional medical devices in a new group would result in a new EC certificate.
  • By issuing the EC certificate, the notified body confirms its review of the technical documentation.

ISO 13485 Certificate

  • The IS−13485IS-13485 certificate is also issued by TUV SUD.
  • This confirms that NDD has set up quality management according to ISO13485ISO 13485.

Medical Device Regulation (MDR)

  • In 2017, the new regulation (MDR) for the EU came into force.
  • Extensive changes between the old Medical Device Directive (MDD) and the new MDR.
  • Impacts are both on products and processes.
  • EZ on PC is the first product that will become MDR compliant.
  • All DOCs and certificates are available on official website.

Certificates

  • NDD also has a Medical Device Single Audit Program (MDSAP) certificate.
  • MDSAP covers unified requirements from five countries: Australia, Canada, Japan, The US, and Brazil.
  • Previously, separate requirements applied and were audited separately for these countries.

Technical File Content

  • The content of a technical file includes various chapters describing the medical device.
  • Most technical files are filed in Teamcenter, and many documents are created in Polarion.

International Product Registrations

  • Registrations in various countries are done through local distributors who are experts in local requirements.
  • The minimal requirement is a reseller letter or distribution agreement signed by the distributor, agreeing to comply with local regulations.
  • For the EU, an MDR agreement is required.
  • In some countries, it makes sense to have product registration through an independent third party, such as an authorized representative, to allocate different distributors.

Time Frames and Efforts

  • Time frames and efforts for product registrations vary:
    • China: 2-3 years (high effort).
    • EU: 6-18 months.
    • USA: 6-9 months.
  • Once a device is registered, the registration certificate is filed, and marketing can begin.
  • Registrations usually have an expiration date and need regular renewal.
  • All valid product registrations are in the country overview list, controlled by regulatory affairs.
  • Sales, export, and customer service need to check whether a product is released for the specific country before sales discussions.

Responsibilities

  • Responsibilities in regulatory affairs are split according to countries and products.
  • If there are any question after the knowledge check, reach out.