Medical devices are an unavoidable part of healthcare. Medical device development happens worldwide but not all devices are being marketed. Only the safe and effective ones are released in to the market for its intended use. This is made sure by the requirements and standards set forward by the health authorities of each country.
Know more about medical devices through this article.
What Is A Medical Device?
According to WHO, “A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose”.
Medical Device Classification And Global Variation
A general classification system is proposed by the International Medical Device Regulators Forum (IMDRF) for medical devices. Medical devices can be classified into 4: A, B, C, and D.
Class | Risk Level | Example |
A | Low Risk | Surgical Retractors, Tongue Depressors |
B | Low -Moderate Risk | Hypodermic needles, Solution Equipment |
C | Moderate - High Risk | Lung Ventilator, Bone Fixation Plate |
D | High Risk | Heart Valves, Implantable Defibrillator |
Medical devices are classified based on the use they are intended for. The higher the risk the more the regulatory requirements. A higher quantity and quality of data must be provided with increasing risk of the device. The risk classification can vary according to the different regulatory requirements in each country.
For example, in the FDA classification, it is divided into 3 classes: Class I, II, III, whereas in EU classification it is classified as Class I, IIa, IIb and III. In both these classifications, classes I and III are the lowest and highest risk respectively. TGA medical device classification is similar to that of the EU system while Health Canada’s classification system has 4 classes, the fourth one is for devices that come under very high risk.
Device classification system determines the regulatory approval pathway of that particular device. For instance, if a device has fallen under class I, which is the lower risk class, the regulatory controls will be more relaxed. On the contrary, if the device falls under Class III, the higher risk class, then the regulatory requirements or conformity assessments are much more demanding like stringent testing, clinical trials, etc.
So, as the risk level increases, it will be hard to be in compliance with the standards or requirements kept forward by the health authorities and these requirements differ with different countries.
ISO Standards For Medical Device Quality Management System
The International Organization for Standardization has established ISO 13485 to provide a harmonized quality management system for medical devices. ISO 13485 was aimed for organizations that are involved in the manufacturing, installing and servicing of medical devices and any related services.
It is also used by the internal as well as external parties like certification bodies to aid them in auditing processes. Every five years, all the ISO standards are reviewed to make sure that they are in compliance with the latest regulatory updates and regulations.
It is not mandatory to get ISO certified, but regulatory bodies have accepted many ISO standards and were also harmonized. Following the ISO standards automatically sets the medical device for regulatory compliance and streamlines the process for its approval. It also assures the safety and efficacy of the product to be used in patients and builds trust for the product while in market.
Requirements For Market Entry Of A Medical Device
In USA, the basic requirements are as follows:
Establishment Registration
Medical Device Listings
Premarket Notification 510(K) - Exempted most Class I devices
Premarket Approval
Investigational Device Exemption (IDE) for Clinical Studies
Quality System Regulations
Labeling Requirements
Medical Device Reporting
In EU, the basic requirements are:
Need to pass the conformity assessment (a process to make sure that the medical device is safe and effective for its intended use) involving an audit of the quality system of the manufacturer.
A detailed review of technical documentation from the manufacturer is also needed depending on the type of device.
A CE mark - to declare that the device is in compliance with all the EU regulations
In high-risk devices, notified bodies are required to request an opinion from the expert panels prior to issuing a CE certificate.
In other cases, before issuing a CE certificate, the notified bodies must ask for EMA’s scientific opinion.
Registration and launching of the device
Labeling
In APAC (Asia Pacific region), the general requirements include:
Registration of the device
Proper classification of the device based on the risk.
Conformity Assessment
Clinical trial data for high-risk devices.
Compliance with quality management systems
In LATAM (Latin America region), the requirements are as follows:
Registration of the medical device
Proper classification of the device based on the risk classification.
Conformity Assessment
Clinical data for high-risk devices.
Compliance with GMP or ISO standards.
Labeling and Packaging
Local representatives for foreign manufacturers.
In MENA (Middle East and North African region), the requirements are:
Registration of the medical devices, need to submit a detailed technical review document and the clinical data (wherever applicable)
Classify the device based on their risk.
Compliance with ISO 13485
Local representative for foreign manufacturers.
Clinical Evaluation And Pre-Market Approval
Clinical evaluation is done to find out whether the medical device is safe for its intended use. It is done prior to the market approval of the device. A clinical evaluation should be detailed enough so as to generate valid evidence of the safety and effective clinical performance of the device. The depth and extent to which the clinical evaluation should expand will be dependent on the nature, intended use and risk of the device.
Pre - Market Approval Application or the PMA is the process of scientific and regulatory review of class III medical devices, the high-risk devices, to assess the safety and effectiveness of them. This is a very strict type of device marketing application. Class III devices are used in supporting and sustaining human life and play a vital role in the prevention of human health impairment.
Data required for PMA includes non-clinical laboratory studies (Microbiology, toxicology, laboratory or animal tests, immunology, biocompatibility, etc.) and clinical investigations (Study protocols, safety and effectiveness data, adverse reactions, complications, patient complaints, patient information and any other information from the clinical investigation).
As we have already discussed, different countries have different standards and regulations for medical devices. Lack of a harmonized standard for medical device approval can be very challenging. Artixio Consulting provides global medical device regulatory services and helps you navigate in a more smooth and effective manner. We have our team of experts to get through different regulations in each country. Reach out to us via info@artixio.com
FAQs
What is Medical Device Regulation (MDR)?
Adopted in April 2017, MDR is a set of regulations that rules the production and distribution of medical devices in the European region. In May 2017, MDR came into effect. It is intended for the safety and quality of medical devices.
What are the key regulatory authorities for medical devices?
The Food and Drug Administration is the regulatory body for medical devices in the US. In Europe, the medical devices are approved by The European Medicines Agency (EMA). The Pharmaceutical and Medical Devices Agency is the regulatory authority for medical devices in Japan. Therapeutic Goods Administration is the regulatory authority for both the drug as well as medical devices. The regulatory body in India is Central Drug Standard Control Organization (CDSCO). Health Canada is for medical device approval in Canada.
Which ISO Standard is applicable for medical devices regarding its quality management system?
ISO 13485 is the standard that is established by ISO for the QMS (Quality Management System) for medical devices. It is done to ensure that the devices follow appropriate standards thereby making sure that they are safe and effective for the use they are intended for. However, it is not mandatory to follow this ISO standard.
What are the general requirements for medical device market entry?
Some general requirements include the registration of the medical device, classifying it correctly, conformity assessment, clinical data of trials conducted if the device belongs to Class III, labeling.
Why is post marketing surveillance needed for medical devices?
Just like how the drugs undergo post marketing surveillance once entered in the market, the medical devices have to undergo it as well. This is done to make sure that the devices are safe and effective for the intended use as long as it is marketed. Moreover, new clinical data is found in this phase, like a new ADR or complication.
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