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: MDR
New Notified Bodies Designated under the MDR and IVDR
MedTech industry is desperately waiting for more Notified Bodies to be designated under the MDR and IVDR. Two more organizations have now been appointed. You may already have heard the… Read More
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
Many important documents and guidance for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) are still missing. In certain aspects, however, things seem to evolve in a direction… Read More
European Commission Website on Regulations MDR / IVDR Restructured
The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More
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
Supportive Information Section mdi Europa
Below we listed a collection of useful documents to support your compliance process. These have been compiled by or on behalf of mdi Europa and are thus not available free… Read More
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
You are a medical device manufacturer and have CE marked your products under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)? Then you must transition… 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
Quality Assurance Agreements (QAA)
Only several months before the Regulation (EU) 2017/745 on medical devices (MDR) fully applies it is time for positive aspects: The MDR contains constructive guidance in many crucial aspects, one… Read More
EU Authorities Might Review Products in Case of Notified Body (NB) Shortage
It seems that the medtech system is on course for calamity because NB designation under the new EU Regulations 2017/745 and 2017/ 746 on medical devices and in vitro diagnostic… 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
Technical Documentation Requirements under the MDR – a Case Study
You may already have asked yourself how Regulation (EU) 2017/745 on medical devices (MDR) affects the Technical Documentation requirements for your products. This is a very complex question and cannot be… Read More
Notified Body Selection and Change
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More
Why is a Clinical Evaluation so Important?
Both, the Medical Devices Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 on Medical Devices (MDR) require manufacturers of medical devices to draw up a clinical evaluation for their devices. The overall aim… Read More
Labeling Changes under the Regulation (EU) 2017/745 on medical devices (MDR)
The MDR brings many challenges for medical device manufacturers. Certainly, an area that requires increased attention and careful planning is labeling. Section 23 of annex I of the MDR defines… Read More