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Oct 142 min read

MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)

The Medical Device Coordination Group (MDCG) has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...

May 252 min read

EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies

The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...

May 62 min read

USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices

Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...

Apr 202 min read

MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...

Jul 17, 20231 min read

MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation

Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...

Jun 20, 20231 min read

USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests

Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...

Feb 14, 20231 min read

EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices

The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical...

Jul 27, 20221 min read

India CDSCO Guidance: 3 IVD Draft Guidances for Consultation

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...