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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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FDA allows access to over-the-counter hearing aids
FDA allows access to over-the-counter hearing aids
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Medical Device Regulation for non-medical products
Medical devices without an intended medical purpose (non-medical products) that fall under the Medical Device Regulation 2017/745.
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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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Diagnostics consultation procedure to the European Medicines Agency - When IVD gets involved
Diagnostics consultation procedure to the European Medicines Agency - When IVD gets involved - companion diagnostics consultation
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Medical Device Labelling Requirements
A label represents the written, printed or graphic information appearing either on the medical device itself, or on the packaging of each...
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MDCG 2022-9 Summary of safety and performance Template
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of...
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MDSAP AUDIT APPROACH
Maybe you are looking to be into the MDSAP program and to benefit for it. We want to provide you the latest guidance on the MDSAP Audit...
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Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745
Check the final guidance from the MDCG. This document provides further explanations and examples clarifying these provisions in order to...
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EU-TURKEY CUSTOMS UNION AGREEMENT IN THE FIELD OF MEDICAL DEVICES
“Whenever the EU instrument listed above [i.e. Regulations 2017/745 or 2017/746] and the relevant Turkish provisions giving effect to...
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REGULATION (EU) 2022/112 - Updates to the In Vitro Diagnostic Medical Devices Regulation
The amendments made to the IVDR transitional provisions do not postpone the IVDR’s entry into application on 26 May 2022. This is...
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The little updating of notified body under IVDR, judges its implementation
The European Commission's update reveals a growing pipeline of submissions approaching MDR designation, but little hope for a short-term...
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What a United Kingdom Responsible Person (UKRP) does?
After December 31, 2020, after the United Kingdom left the European Union, the United Kingdom faced a new regulatory situation. It has...
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CONCLUSIONS FOR A CLINICAL EVALUATION - MDR
A successful clinical investigation for Medical Device Regulation EU 2017/745 (MDR) is one that generates scientifically valid clinical...
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Declaration of conformity for medical devices
The Declaration of Conformity (also known as DoC) is a critical document for every medical device in Europe.
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Are you looking for an MDR Technical File template?
MDR Technical File template
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Content of Premarket Submissions for Device Software Functions
The FDA just published draft guidance on Premarket Submissions for Device Software Functions. It describes the information the FDA...
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Formal proposal to delay IVDR
#BreakingNews We now have a formal proposal from the European Commission to delay #IVDR. The proposal does not change any requirements of...
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A new MDCG Guidance has just been released, namely 2021-25
The document addresses a crucial issue, often confusing for manufacturers, authorized representatives, importers and distributors, the...
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