On September 25, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the application of transitional provisions for the certification of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746 (MDCG 2021-4). This
The FDA has just released an updated version of its Control of Nitrosamine Impurities in Human Drugs Guidance, introducing crucial changes for pharmaceutical manufacturers.
On July 8th, 2024, the Medical Device Coordination Group (MDCG) released its third revision on the guidance for classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG 2020-16 Revision 3). The updates include a new definition
On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations (EU) 2017/745 or the Medical Device Regulation (MDR) and Regulation (EU) 2017/746 or the in vitro diagnostic medical
On July 2nd, 2024, the Medical Device Coordination Group (MDCG) released a first revision on the guidance on standardization for medical devices (MDCG 2021-05 Revision 1). The scope of this document is to provide guidance on different aspects related to
On 04/07/2024, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/154403/2024 /Rev. 5) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are listed.
On June 25th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10).
On June 11th, 2024, the Medical Device Coordination Group (MDCG) released a new Device Specific Vigilance guidance(MDCG 2024-1-5 – DSVG 05) for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.
On June 17th, 2024, the Medical Device Coordination Group (MDCG) released a new revision of the guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply
On May 27th, 2024, the Medical Device Coordination Group (MDCG) released a second revision on the guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the
On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.
On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body survey on certifications and applications under the MDR and IVDR with data until February 29th, 2024.
On May 26th, 2024, all but one requirement for in-house devices under Article 5(5) under Regulation (EU) 2017/746 or the in vitro diagnostic medical device regulation (IVDR) shall finally enter into force.
In-house devices are IVDs that are exempted
On 01/05/2024, the European Medicines Agency (EMA) rolled out an update to Appendix 1 (EMA/154403/2024 /Rev. 4) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are listed.
On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations 2017/745 MDR, and 2017/746 IVDR as regards a gradual roll-out of Eudamed, information obligation in case of
New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and set to come into effect on September 1, 2024, stipulates that an ERA report will be
On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices under Regulation (EU) 2017/745 or the medical device regulation (MDR) (MDCG 2024-5).
On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) as per Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic
The Medical Device Coordination Group (MDCG) released a guidance document on the content of the Clinical Investigation Plan for clinical investigations of medical devices
The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 –
Here you find all news related to Regulatory Affairs
Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.