Notes on Regulations Governing the Export of Medical Devices

Background

Medical devices marketed in the US are subject to the Title 21 of the Code of Federal Regulations (CFR) – Food and Drugs that includes the definitions, classification and regulatory requirements for medical devices. Other regulations that may be applicable include:

• California Proposition 65 (CP 65), enacted by the state of California to ensure the safety of drinking water, requires businesses to execute the obligation to give warnings for listed chemicals.
• The Public Law 104-142 (HR2024) on batteries in the US establishes restrictions on the use of hazardous substances in batteries.
• The TPCH Legislation on packaging materials in the US establishes restrictions on the use of hazardous substances in packaging materials.

The medical devices marketed in the EU are subject to following regulations:

• Medical Devices Regulation (EU) 2017/745

It will replace the Council Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices (AIMD)

• In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

It will replace the Council Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).

IVDR 2017/746 sets forth the definitions, classification rules and procedural requirements for medical devices.

Other regulations that may be applicable include:

• Directive 2011/65/EU establishes restrictions on the use of certain hazardous substances in electrical and electronic products available for sales or supply in the EU.
• Regulation (EC) No 1907/2006 establishes restrictions on the use of certain chemicals in all substances, mixtures and articles manufactured and marketed in the EU. Relevant articles shall conform to the requirements for substances of very high concern (SVHC) in Article 33 of the Regulation and requirements in Article 67 and Annex XVII.
• Regulation (EU) 2019/1021 establishes restrictions of the use of persistent organic pollutants (POPs) in all substances, mixtures and articles in the EU.
• Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) in the EU addresses the recycling symbol and recovery rate.
• Directive 2006/66/EC on batteries in the EU contains restrictions on certain substances and requirements on symbols.
• Directive 94/62/EC on packaging materials in the EU establishes restrictions on the use of hazardous substances in packaging materials.

Scope

In the US, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, which is intended for use in the diagnosis of human disease or other conditions; in the cure, mitigation, treatment or prevention of disease; or intended to affect the structure or any function of the human body; and which does not achieve its primary intended purposes through chemical action within or on the human body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

According to the EU's new medical device regulation, a medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations; and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Products specifically intended for the cleaning, disinfection or sterilization of devices and devices for the control or support of conception shall also be deemed to be medical devices.

Regulations

The US

Title 21 of the CFR – Food and Drugs classifies medical devices based on the risks associated with the devices into class I (low risk), class II (moderate risk) and class III (high risk). The FDA assigns each device a Unique Device Identifier (UDI) and specifies the standards for devices.

a. Class I (Low Risk)

Class I medical devices refer to devices that present low or basically no risk and are subject to general controls. These devices are typically simpler than class II and class III devices in design. The FDA believes that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of most class I devices. Class I devices such as medical gloves, tongue depressors and manual surgical instruments are subject to general controls, including device registration and listing with the FDA.

For more information, please refer to Device Registration and Listing.

b. Class II (Moderate Risk)

Class II devices refer to devices for which general controls are insufficient to provide reasonable assurance of safety and effectiveness of the devices and which require other existing means, i.e. special controls, to ensure their safety and effectiveness, such as thermometers, ECG monitors, ultrasound systems, transfusion and infusion equipment and ventilators. These devices can only be placed on the market after a Premarket Notification 510(k) is granted.

For more information, please refer to 510(k).

c. Class III (High Risk)

Class III medical devices refer to devices for which general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the devices. Class III devices are life-supporting or life-sustaining devices preventing impairment of human health and present a high or potentially unreasonable risk of illness or injury to a patient, such as artificial cardiac valves, cardiac pacemakers, intraocular lens and artificial blood vessel. These devices require a Premarket Approval (PMA).

For more information, please refer to Premarket Approval (PMA).

In terms of chemicals, other regulations that may be applicable include:

The EU:

The EU Medical Devices Regulation classifies medical devices into classes I, IIa, IIb and III.

• Class I is a non-invasive instrument, except those intended for storing blood, use with a class IIa, class IIb or class III device, modifying the composition of body liquids, and use in contact with the dermis.
• Class IIa devices include devices intended for diagnosis, channelling or storing body liquids and surgically invasive devices intended for transient use (continuous use for less than 1 hour).
• Class IIb devices are surgically invasive devices intended for short-term use (continuous use for between 1 hour and 30 days), and those used for contraception and radiology.
• Class III devices are devices intended for use in direct contact with the central nervous system or heart, devices intended to be absorbed by the human body, implantable devices, devices intended to administer medicinal products and surgically invasive devices intended for long-term use (continuous use for more than 30 days).

a. Class I (Low Risk)

The medical device directive/regulation explicitly sets out the classification rules, basic safety and performance requirements and evaluation process for class I devices. Class I medical devices include measuring (Im)/sterile (Is) and other devices; the non-measuring/non-sterile class I devices can be self-declared for CE compliance; classes Im and Is devices require a CE certificate from a Notified Body.

b. Class II (Moderate Risk)

The medical device directive/regulation explicitly sets out the classification rules, basic safety and performance requirements and regulatory requirements for class II devices. To put a class II device on the market, a manufacturer must submit an application to a designated notified body who then reviews the conformity of the device and issues the manufacturer with a CE certificate if the device meets applicable regulatory requirements (for a class IIa device designed by the manufacturer, the notified body reviews the quality system; for a class IIb device, the notified body reviews the quality system and inspects the products on the sampling basis, and the manufacturer shall submit the product design document). With a CE certificate, the device can be placed on the EU market.

c. Class III (High Risk)

The medical device directive/regulation explicitly sets out the classification rules, basic safety and performance requirements and regulatory requirements for class III devices. Class III devices shall be subject to the review by a notified body who inspects its quality system and products on the sampling basis and reviews the product design document, especially the risk analysis report. The notified body then issues a CE certificate if the device meets applicable regulatory requirements. With a CE certificate, the device can be placed on the EU market.

In terms of chemicals, other regulations that may be applicable include:

Legal Basis

For more information about medical device regulations, please refer to:

The US

https://www.ecfr.gov/cgi-bin/text-idx?SID=3b4adc545b86bfc3d544199729f39d46&mc=true&tpl=/ecfrbrowse/Title21/21cfrv8_02.tpl#0

https://oehha.ca.gov/proposition-65

https://www.epa.gov/rcra/mercury-containing-and-rechargeable-battery-management-act-public-law-104-142

The EU

https://ec.europa.eu/health/md_sector/overview_en

https://eur-lex.europa.eu/eli/dir/2011/65/oj

https://echa.europa.eu/regulations/reach/understanding-reach

http://data.europa.eu/eli/reg/2019/1021/oj

http://data.europa.eu/eli/dir/2012/19/oj

http://data.europa.eu/eli/dir/2006/66/oj

http://data.europa.eu/eli/dir/1994/62/oj

Remarks:

1.      Medical device manufacturers shall establish and maintain a complete and effective quality management system.

Note: The above information does not constitute any legal advice and shall not be deemed or represent the legal opinion or conclusion of the regulatory body. Further, we do not undertake or warrant that the information represents the latest laws and regulations. For specific information, consult the competent authority, law firms, or third-party certification/testing/consulting companies in the target country or region.
 

AliExpress
August 31, 2020

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