Medical Devices 101 | Your Questions | November 2023

Medical devices face a 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 an 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 the registration, and inspection of medical devices under MDR means staying ahead is more critical than ever.

In this series, we gather some of the most interesting recent inquiries from Compliance & Risks customers regarding medical device regulatory updates globally.

Question 1: Please provide more information on EU: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Regulation (EC) 1907/2006 – Proposed Amendment – (on adding octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) to Annex XVII) Draft Regulation, June 2023

The proposed restriction under this draft amendment to REACH Annex XVII will apply 2 years after the date of entry into force of the regulation. There has been no new developments on this draft EU Commission proposal aiming to complement the existing restriction of D4 and D5 in wash-off cosmetic products in REACH Annex XVII, by restricting the placing on the market of D4, D5 and D6 on their own, as a constituent of other substances (but excluding polymers), and in mixtures in other consumer and professional products.

With respect to past EU Commission drafts amendment to Annex XVII, we assume that this proposal could be finally adopted by the end of this year.

Question 2: What is the definition of Active Medical Devices per Law 26906 in Argentina?

As per Article 3 of the Traceability and Technical Suitability Verification of Active Medical Devices in Use, Law No. 26906 2013, the definition of an Active medical product is any medical product whose operation depends on electrical energy or any source of power other than that generated by the human body or gravity and that works by the conversion of this energy.

Medical products intended to transmit, without causing any significant alteration, energy, substances or other elements of an active medical product to the patient will not be considered active medical products.

Question 3: What are the requirements for the new EU Batteries Regs 2023, with regards to removability and replaceability requirements?

The EU Batteries Regulation is intended to apply to all batteries, including industrial batteries and batteries incorporated into industrial products. The removability requirement is relaxed for medical products and devices used in wet environments, but all batteries should be removable and replaceable. The relevant text is as follows:

Article 11. Removability and replaceability of portable batteries and LMT batteries

“1. Any natural or legal person that places on the market products incorporating portable batteries shall ensure that those batteries are readily removable and replaceable by the end-user at any time during the lifetime of the product. That obligation shall only apply to entire batteries and not to individual cells or other parts included in such batteries. A portable battery shall be considered readily removable by the end-user where it can be removed from a product with the use of commercially available tools, without requiring the use of specialised tools, unless provided free of charge with the product, proprietary tools, thermal energy, or solvents to disassemble the product. Any natural or legal person that places on the market products incorporating portable batteries shall ensure that those products are accompanied with instructions and safety information on the use, removal and replacement of the batteries. Those instructions and that safety information shall be made available permanently online, on a publicly available website, in an easily understandable way for end-users. This paragraph shall be without prejudice to any specific provisions ensuring a higher level of protection of the environment and human health relating to the removability and replaceability of portable batteries by end-users laid down in any Union law on electrical and electronic equipment as defined in Article 3(1), point (a), of Directive 2012/19/EU.

2. By way of derogation from paragraph 1, the following products incorporating portable batteries may be designed in such a way as to make the battery removable and replaceable only by independent professionals:

(a) appliances specifically designed to operate primarily in an environment that is regularly subject to splashing water, water streams or water immersion, and that are intended to be washable or rinseable;

(b) professional medical imaging and radiotherapy devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745, and in vitro diagnostic medical devices, as defined in Article 2, point (2), of Regulation (EU) 2017/746. The derogation set out in point (a) of this paragraph shall only be applicable where such derogation is required to ensure the safety of the user and the appliance.

3. The obligations laid down in paragraph 1 shall not apply where continuity of power supply is necessary and a permanent connection between the product and the respective portable battery is required to ensure the safety of the user and the appliance or, for products that collect and supply data as their main function, for data integrity reasons.“

Stay Compliant With Global Medical Device Regulations:

Catch up on our medical device updates with your coffee here:

• Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan
• Regulatory Trends in Medical Devices: A 12-18 Month Outlook
• Keeping Pace with Change: Recent Regulatory Updates Shaping Medical Device Compliance
• European Commission Publishes MDR and IVDR Factsheet for Non-EU/EEA Countries

Have you got a Medical Device related query?

Many of the above questions were submitted and answers were conveyed by 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.

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