Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

Maria

EC Rep Now

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

Soledad

GPSR 2023 988

The EU’s GPSR 2023/988 enforces stricter product safety, online marketplace accountability, and better recall processes for consumer protect

Soledad

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!

Soledad

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

Soledad

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.

Soledad

Examples of Class III medical devices

Medical Device classification under MDR. Examples of MDR class III medical devices

Soledad

Examples of Class IIb medical devices

Medical device classification examples. Class IIb under MDR rules.

Soledad

Examples of EU Medical Device - Class I

Examples of medical devices classes

Soledad

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.

Soledad

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...

Soledad

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

Soledad

Border line products?

#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU)...

Soledad

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