Manufacturers of medical devices are eagerly waiting for more guidance on the implementation of the MDR. MDCG has now issued a useful guidance on the Summary of Safety and Clinical… Read More
MDCG Guidance on MDD Certificates and SSCP under the MDR
Tag: Guidance Documents
Complete Download Section mdi Europa
The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 20 important… Read More
Guidance on Person Responsible for Regulatory Compliance
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR. There… Read More
Guidance on Implant Cards
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the Implant Card (IC) according to article 18 of the MDR. It makes sense to review the… Read More
Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics
The Medical Devices Coordination Group (MDCG) has published a number of guidance documents on the topic of UDI over the past months. More recently, the MDCG issued guiding principles for… Read More
EU Guidance on Quality Rules for Drug-Device Combinations
The long overdue guidance on quality expectations for regulatory filings in the EU concerning integral and other kinds of drug-device combination (DDC) is available in draft form for public consultation.… Read More
The World Health Organisation’s (WHO) New Draft Guideline
The WHO is looking for comment on its proposal to combine the features of good storage and distribution for medical products into a single guidance document and will be applicable… Read More
Draft Policy on Remaining Shelf-Life for Medical Products
The World Health Organisation (WHO) was looking for feedback from stakeholders on a draft policy which gives details of how medical devices, diagnostics and other medical products should be managed… Read More
Updated Clinical Evaluation Guidance on Comparability
In an effort to bring its guidance documents on clinical evaluation up to date, the International Medical Device Regulators Forum (IMDRF) has asked for feedback on proposed revisions to three… Read More
Device Registration and Legacy Devices
The European Commission’s Medical Devices Coordination Group (MDCG) recently published two guidance documents on timelines for device registration and on registration expectations for manufacturers of legacy devices. Legacy devices in… Read More
Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)
The Medical Device Coordination Group (MDCG) has published a guidance document on the interpretation of article 54(2)b of the MDR. The aforementioned article provides criteria for the exemption of medical… Read More