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Global Harmonization of Regulatory Requirements for Medical Devices

Global Harmonization of Regulatory Requirements for Medical Devices

Global Harmonization of Regulatory Requirements Medical Devices

Amy Eikelenboom

Co-founder of NAALA

Published on 11 August 2021

Regulatory requirements for medical device registration vary greatly on national level. Harmonization is required to enhance patient safety and increase access to safe, effective and clinically beneficial medical technologies around the world.  

In 1992 the Global Harmonization Task Force (GHTF) was founded. In 2012, the GTHF was succeeded by the International Medical Device Regulators Forum (IMDRF). The goal of the GHTF was to achieve greater uniformity among national requirements.  

The following countries and continents are current IMDRF members: Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea and the US 

Europe being a IMDRF member, it is no surprise the IMDRF definition of a (n in vitro diagnostic) medical device overlaps with the definition in the European Medical Device Regulation.    

IMDRF defines (in vitro diagnostic) Medical Devices the following way: 

Medical device means 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 human beings, for one or more of the specific medical purpose(s) of: 

  • diagnosis, prevention, monitoring, treatment or alleviation of disease, 
  • diagnosis monitoring, treatment alleviation of or compensation of an injury, 
  • investigation, replacement, modification, or support of the anatomy or of a physiological process, 
  • supporting or sustaining life, 
  • control of conception, 
  • disinfection of medical devices, 
  • providing information by means of in vitro examination of specimens derived from the human body; 

And does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.  

The Safety and Performance principles of the IMDRF are based on six general requirements applicable to all medical devices: 

  1. Medical devices should be designed and manufactured in such a way that they will not compromise patients, users or, other individuals’ clinical condition or safety. The conditions and the purposes intended as well as any education or training required, should be taken into account. This should be weighed against the benefits and risks to the patient.  
  1. The design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. When risk reduction is required, the manufacturer should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable. The manufacturer should apply the following principles in the priority order listed: 
  1. identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse 
  1. eliminate risks as far as reasonably practicable through inherently safe design and manufacture 
  1. reduce as far as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms 
  1. inform users of any residual risks. 
  1. Devices should achieve the performance intended by the manufacturer. 
  1. Device characteristics and performances should not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device. 
  1. The devices should be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected under transport and storage conditions. 
  1. The benefits must be determined to outweigh any undesirable side effects for the performances intended. 

To place a (n in vitro diagnostic) medical device on the market, manufacturers must demonstrate conformity to the minimum safety and performance requirements via the: 

  • Quality management system (QMS) 
  • Post-market surveillance system 
  • Technical documentation  
  • Declaration of conformity 
  • Manufacturer and medical device registration with the regulatory authority 

These requirements are generally required in each jurisdiction; however, specific requirements may be expected.  

  • Class A: Lowest risk class, such as surgical retractors and tongue depressors; 
  • Class B: moderate to medium risk, such as hypodermic needles and suction equipment; 
  • Class C: moderate to high risk, such as lung ventilators and a bone fixation plate; 
  • Class D: highest risk, such as heart valves and implantable defibrillator. 

The IMDRF and its essential principles of safety and performance have the ability to help manufacturers design and manufacture (in vitro diagnostic) medical devices while reducing costs due to jurisdictional differences. Conformity is a prerequisite in most countries as conformity assessments and classification apply universally.  

Need assistance to determine your global regulatory strategy? Feel free to contact us.  

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis. 

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