📌𝟱. 𝗠𝗮𝗿𝗰𝗵 𝟮𝟬𝟮𝟯
Martin King
✅𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 & 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗘𝘅𝗽𝗲𝗿𝘁 | Open to New Challenges | Medical Device, IVD | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | 𝙢.𝙠𝙞𝙣𝙜@𝙗𝙡𝙪𝙚𝙬𝙞𝙣.𝙘𝙝
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📌European Commission
📌Agenda, 9. March 2023: Scientific Committees on Health, Environmental and Emerging Risks (SCHEER) 4th Plenary meeting (2022-2026)
Request for the update of Guidelines (see below) on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine disrupting (ED) properties.
📌Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
This is important for medical device manufacturers to monitor as a number of exemptions for materials listed in Annex III expire during 2023.
📌COMMISSION STAFF WORKING DOCUMENT EVALUATION of Electromagnetic Compatibility Directive 2014/30/EC
For manufacturers of electrical and electronic medical equipment.
📌Therapeutic Goods Administration
Guidance on the transitional arrangements and obligations
Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin.
📌FDA
📌Draft Guidance: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens Guidance for Industry
📌Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry
This is the same as International Council for Harmonization (ICH) Quality guidance Q13 released November 2022.
📌eMDR System Enhancements
For medical device manufacturers submitting eMDR reports via an AS2 Account with the FDA Electronic Submissions Gateway (ESG), be ready for Production Deployment of eMDR enhancements on March 17, 2023.
📌Team-NB
📌MedDRA MSSO
Medical Dictionary for Regulatory Activities
Version 26.0 has been released (4 documents)
MedDRA is a standardized international medical terminology dictionary, providing a common language for the classification of medical information related to drug safety and regulatory activities, important for regulatory authorities, pharmaceutical companies, healthcare professionals, and patients. It helps improve the quality and consistency of adverse event reporting and other medical data, facilitating the identification of potential safety concerns and the development of appropriate risk management strategies, ultimately promoting the safety and efficacy of medicinal products and protecting public health.
📌#RareDiseaseDay 28. February 2023
📌Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
📌European Commission.
This is an apology for inaction and an opinion looking forward:
📌European Medicines Agency
A very useful factsheet:
📌Department of Health and Social Care
📌Medicines and Healthcare products Regulatory Agency
A very easy to follow Medical Device Registration Reference Guide:
📌Swissmedic
Recommended by LinkedIn
📌Guidance: Mobile Technologies
📌Guidance: Document Packaging Texts Veterinary Products
📌Guidance: Document Packaging Human Medicinal Products
📌Guidance: Simplified Manufacturing Information
📌Guidance: Changes to establishment licences.
📌Guidance:Third-party maintenance of software updates,Inspection, repair, preparation....
In German: Leaflet detailing guidance for third-party maintenance of software updates,Inspection, repair, preparation for first use and preparation for reuse,to maintain or restore the functional condition of a medical product.
📌List of all countries with comparable control (of human medicinal products)
📌European Medicines Agency
EMA has launched a pilot project to provide scientific advice on the intended clinical development strategy for ten selected high-risk #medicaldevices.
📌GOV.UK The Windsor Framework
"The agreement safeguards frictionless access to the EU market for world-leading Northern Ireland pharmaceutical and medical technology firms. This pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom"
- UK legislation applies to Northern Ireland rather than EU legislation BUT
- Medicines and Healthcare products Regulatory Agency to approve drugs for the whole UK market including Northern Ireland.
- If the product has only be approved in the UK then it should be marked "Not for Europe".
- Falsified Medicines Directive will NOT apply to Northern Ireland.
- Innovative drugs approval will be under UK regulatory system rather than managed by European Medicines Agency.
📌Medical Device Authority Ministry Of Health, Malaysia (KKM)
FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0064: NOTIFICATION OF CUSTOM-MADE MEDICAL DEVICES
A medical device made with a specific design characteristic in accordance with a healthcare professional’s written prescription and is intended to be used for a particular patient.
📌Egyptian Drug Authority
📌Good Manufacturing Practices Training Program and Technical Support for Technicians and Workers
The deadline for participation and payment of the training fee is on Wednesday, March 9, 2023.
The training program is scheduled to start on Sunday, March 12, 2023, for a period of six training days.
📌A training course to introduce the licensing procedures for pharmaceutical factories.
The deadline for participation and payment of the training fee is on Sunday, March 12, 2023.
The training program is scheduled to start on Monday, March 13, 2023.
Managing Director at SAQ as well as passionate Co-Active, ACC and ORSC Coach at Green Wave CC
1yNice update Martin!