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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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Maria
EC Rep Now
AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.


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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.


Maria
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.


pharmaserviceinc
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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