Medical Devices 101 | Your Questions | September 2024

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 our Medical Devices 101 series, we gather some of the most interesting recent inquiries from Compliance & Risks customers regarding medical device regulatory updates globally.

Question 1: Is Charcoal used in medical devices included in the scope of the EU Regulation (EU) 2023/1115 on Making Available on the Union Market and Export from the Union of Certain Commodities and Products Associated with Deforestation and Forest Degradation (EUDR) or are they are exempted?

In terms of derived products, only the products listed in the Annex to the EUDR are in scope of the EUDR. The products are indicated by means of their HS/ Tariffs codes. Medical devices as a product are not on the list in Annex I and therefore not covered by the EUDR.

Question 2: Regarding the Albania Regulation on the Rules and Obligations of Manufacturers and Importers Regarding the Registration and Reporting of Chemicals, Decision No. 449/2024, are medicinal products exempt from the reporting requirement?

Yes. Albania, as an EU candidate country, has been developing and aligning for some time, and its chemicals management system with the EU regulatory framework. In this regard, this regulation in accordance with Section 4 paragraphs (2) and (4) of the country’s 2016 chemicals management Law largely modelled on EU REACH, exempts medicinal products alongside cosmetics, medical devices, veterinary products, foodstuffs, or animal feed, etc. from the registration and reporting requirements.

Question 3: What is the scope of Pennsylvania (USA) House Bill 2241 on Establishing Stewardship Plan for Batteries, from April 2024 and does the bill exclude batteries contained within medical devices?

Yes, based on the definition of “Covered battery” in § 6703 of Pennsylvania House Bill 2241 (2024), a battery contained within or packaged with a medical device that is not designed and marketed for sale or resale principally to consumers for personal use is excluded from the bill.

Stay Compliant With Global Medical Device Regulations:

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

• Stay Compliant: Medical Device Industry 2024 Regulatory Update
• Medical Devices Regulatory Updates in North, Central and South America
• Medical Device Regulation Checklist: Brazil
• Regulatory Trends in Medical Devices: A 12-18 Month Outlook
• Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan
• European Union (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR) and Cybersecurity

Medical Devices 101: Have you got a Medical Device related query?

Many of the Medical Devices 101 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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