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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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EC Rep Now
AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.
Maria
GPSR 2023 988
The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect
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New AI Act Regulation
Europe's AI Act enforces transparency, safety, and accountability in AI, ensuring responsible use and protecting consumers from risks.
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Legacy Devices (MDD CE marked devices)
Navigating the transition from MDD to MDR for Legacy Medical Devices, medical devices with CE marking under MDD. Check the information!
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New Draft Compromise Amendments for AI in the EU
A new Draft Compromise Amendments for AI in the EU has been published and you can download it below. Also, AF Pharma can help you.
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Regulatory Landscape for Custom-Made Medical Devices in the EU
Navigating the complex regulatory landscape of the European Union (EU) can be overwhelming when seeking compliance, registration, and succes
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Do you want to have a CE mark? Follow the steps below
A CE mark logo is an essential identification for certain products in the EU, including medical devices and machinery.
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Examples of Class III medical devices
Medical Device classification under MDR. Examples of MDR class III medical devices
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Examples of Class IIb medical devices
Medical device classification examples. Class IIb under MDR rules.
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Examples of EU Medical Device - Class I
Examples of medical devices classes
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Foods for special medical purposes/medical foods: A global regulatory synopsis
Foods for special medical purposes/medicinal foods have different regulations depending on where they are manufactured or sold.
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MDR and IVDR Delay!
Today, 6th January 2023, the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of...
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EU Health Commissioner proposes MDR delay to prevent medical device shortages
The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years
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Border line products?
#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...
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Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/
Classification of in vitro diagnostic as per Regulation (EU) 2017/746
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