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Medical Devices 101: A Review Of The Most Interesting Inquiries of 2022

Jan 03, 2023 Medical Devices 101: A Review Of The Most Interesting Inquiries of 2022

Medical devices face their own unique regulatory landscape that has been increasingly complicated by several factors in recent years.

The demand for more sustainable technology is being driven by both consumer demand and legislators, leading to regulatory implications. Global events such as Brexit and COVID-19 have also created unprecedented challenges.

As devices become increasingly integrated with artificial intelligence and internet connection, new cybersecurity and data protection legislation is racing to keep up.

And on top of all this, the new regulatory framework for IVDR and proposed amendments for registration & inspection of medical devices under MDR means staying ahead is more critical than ever.

In this series, we review some of the most interesting inquiries Compliance and Risks received from customers in 2022 regarding the medical device regulatory updates globally:

Question 1: Article 3 (Scope of Application) of the Registration and Assessment of Chemical Substances, Law No. 11789, 2013 (K-REACH) states that the act does not apply to Medical devices under Article 2 (1) of the Medical Devices Act. IVDs appear to be under the original scope of the Medical Device Act.

However, The MFDS (Ministry for Food and Drug Safety) issued a new act, called the In-vitro Diagnostics Medical Devices Act, effective as of May 2020. This act now distinguishes IVDs from the rest of medical devices.

Does K-REACH still exempt IVDs now that they have their own act?

South Korea: Designation of Priority Substances under K-REACH, Notice No. 2018-233 – Amendment – (on addition and deletion of priority substances, etc.) Notice No. 2022-79

Denise McDermott, Senior Regulatory Compliance Specialist answers:

Our Korean speaker has reviewed the texts for this query. Article 3 of the most recent consolidation (Law No. 18034) of the K-REACH Law dated 13 April 2021, states that this Act does not apply to chemicals that fall under Article 2(1) of the Medical Device Act. This Article does not mention products under the In Vitro Diagnostic Medical Device Act enacted on April 30, 2019.

In Article 2(1) of the Medical Device Act, “medical device” means an machine, apparatus, material, software, or any other similar product specified in the following as one used, alone or in combination, for human beings or animals:

  • A product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease;
  • A product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment;
  • A product used for the purpose of testing, replacing, or transforming a structure or function;
  • A product used for the control of conception.

Therefore, from the texts available to us, if a product falls within the scope of Article 2(1) of the Medical Device Act above, it appears to be excluded from the application of the K-REACH Law. 

Question 2: If medical electronic devices / in vitro diagnostic electronic instruments with leaded internal components are able to be sold in 50 U.S States, even if the states do have Rohs like regulation to restrict the 10 restricted substances. From what I am able to gather, medical devices are not in scope for the states that do have rohs regulation.

Medical Devices with lead in USA

Denise McDermott, Senior Regulatory Compliance Specialist answers:

Yes, some US states have implemented RoHS type restrictions, however these only cover specific electronic devices as outlined below.


California RoHS restricts several substances including lead and applies to “covered electronic devices” that are defined as a cathode ray tube, cathode ray tube device, flat panel screen, or any other similar video display device with a screen size that is greater than four inches in size measured diagonally and which the department determines, when discarded or disposed, would be a hazardous waste.

Covered electronic device does not include “an automobile or a large piece of commercial or industrial equipment, including, but not limited to, commercial medical equipment, that contains a cathode ray tube, cathode ray tube device, flat panel screen, or other similar video display device that is contained within, and is not separate from, the larger piece of industrial or commercial equipment.

New Jersey

The New Jersey Electronic Waste Management Act, also restricts lead for certain electronic devices. The Act regulates the sale of covered electronic devices if the amount of the restricted substance is too high as per the EU RoHS Directive. The electronic devices covered include; computers, computer monitors and televisions.

According to the Act “Covered electronic device” means a desktop or personal computer, computer monitor, portable computer, or television sold to a consumer. A “covered electronic device” shall not include “an electronic device that is functionally or physically a part of a larger piece of equipment designed and intended for use in an industrial, commercial, or medical setting, including diagnostic, monitoring, or control equipment


The Electronic Waste Act issued by the Indiana General Assembly in Indiana, also includes restrictions on lead and products in scope include video display devices.

Devices registered require a statement that discloses whether “any video display devices sold by the manufacturer to households exceed the maximum concentration values established: (i) for lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (pbbs), and polybrominated diphenyl ethers (pbdes); and (ii) under the directive restricting the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) 2002/95/EC of the European Parliament and Council, as amended; or (B) the manufacturer has received an exemption from any of the maximum concentration values under the RoHS Directive that has been approved and published by the European Commission.

New York

In New York, the Electronic Equipment Recycling And Reuse Act restricts the use of lead and includes the following electronic devices in its scope; computers, computer peripheral, small electronic equipment (which means means any portable digital music player that has memory capability and is battery-powered, video cassette recorder, a digital video disc player, digital video recorder, digital converter box, cable or satellite receiver, or electronic or video game console, and includes any cable, cord, or wiring permanently affixed to or incorporated into any such product), small-scale servers, cathode ray tubes and televisions.

Covered electronic equipment in this act does not include commercial medical equipment that contains within it a cathode ray tube, or other medical devices as that term is defined under the Federal Food, Drug and Cosmetic Act.


In Illinois, the Illinois Electronic Products Recycling and Reuse Act also restricts lead and covers televisions.


In Wisconsin, the Wisconsin Electronic Waste Recycling Act requires that manufacturers disclose compliance with the substance restrictions set out by the EU RoHS Directive. Covered Products include computer Equipment and monitors, mobile / cell phones, modems and televisions.

Question 1: Is the reparability index for EEE in France applicable to Medical Devices?

French Repairability Index

Answered by Denise McDermott, Senior Regulatory Compliance Specialist

The French repairability index applies to 5 categories of electrical and electronic equipment products sold in France after 1 January 2021 including: Smartphones, Laptops, Televisions, Washing machines and Lawnmowers.

From November 4, 2022, four new product categories will be affected (top washing machines, dishwashers, vacuum cleaners, high-pressure cleaners.)

Stay Compliant With Global Medical Device Regulations:

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Your Questions Answered

Many of the above questions were submitted and answers were conveyed to Compliance & Risks customers via the “Ask Our Experts” button in C2P

Clients use AOE to ask about the latest proposed, enacted and amended regulations and mandatory standards applicable to their products and geographies of interest. 

When AOE questions can be answered in 30 minutes or less, Compliance & Risks’ subject matter experts answer them at no charge!

To learn more about C2P and how Compliance & Risks’ SMEs can help you with your questions, contact us today.