MEDIcept Insights
MDCG Urges Compliance To EU’s MDR/IVDR In 19-Point Action Plan
The Medical Device Coordination Group (MDCG) this week urged manufacturers to make sure they’re in “timely compliance” with the EU’s MDR and IVDR regulations to help stave off product shortages. In a position paper released on Aug. 30, “Transition to the MDR and IVDR:...
U.K. MHRA Gives Device Makers More Time To Comply With New Reg Framework
As the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) transitions to a new post-Brexit regulatory framework, it has announced that medtech companies will get extra time to comply with regulations. This is good news for the industry, which has faced...
Guidance on IVDR Significant Changes
Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...
EUDAMED Database – Progress Updates
EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR).
The FDA and Medical Device Cybersecurity
Healthcare providers are a prime target for cyberattacks due to many interconnected medical devices and the sensitive patient data they house.
Are Your Policy And Procedures In Place To Be Recall Ready?
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...