Presentation of Qualitiso’s Monitoring Activities
Regulatory and Standards Monitoring for Medical Device Manufacturers
- Monitor developments through articles analysing the latest developments
- Configure automated monitoring
- sources, standards committees, and be informed within hours of new developments
- Add your own sources on request!
Medical Device Regulatory Intelligence
- View the latest developments in automated feeds
- The most important news is summarised and analysed in regulatory intelligence articles
Description
| Feed | Description | Purpose | How it works | Available language |
|---|---|---|---|---|
| Regulatory intelligence articles | The sector’s main regulatory and standards news, summarised and analysed | Identify the main developments | Alerts via the newsletter, at your chosen frequency | French or English |
| Regulatory and General News | Regulatory and general news | Identify regulatory developments in the sector | Filtered according to the characteristics of your devices and your activities. Coverage: up to 10 news items per source, covering up to 100 days. | French or English, depending on the source |
| ISO Standards | International standards news: new publications | Identify developments in international standards | Unfiltered; standards are classified by subject and year. Coverage: all standards are included. | French and English |
| EN Standards | European standards news: new publications | Identify developments in European standards | Filtered according to the characteristics of your devices and your activities. Coverage: all standards are included. | French and English |
| NF Standards | French standards news: new publications | Identify developments in French standards | Filtered by committee. Coverage: the 30 most recently published standards from each committee. | French only |
| Draft Standards Under Public Enquiry | French standards news: public enquiries | Identify standards developments from the public enquiry stage | This feed is not filtered. Coverage: the 30 most recently published public enquiries. | French only |
List of Monitored Sources
| NEWS | ISO | CEN/CENELEC | AFNOR |
|---|---|---|---|
| AFCROS: News ANSM: News CAMD: News ChinaMed: Blog CM DM: Blog COCIR: New position paper Confindustria Dispositivi Medici: News Device Med: News EMA: EMA news on medical devices EU: Medical devices – In vitro diagnostics – Latest updates EU: Research and innovation news alerts EU: Notified body notifications under Regulation (EU) 2017/745 EU: Notified body notifications under Regulation (EU) 2017/746 EU: Digital health – Latest updates EU: Medical devices – Sector – Latest updates EU: Scientific committees – News EU: Medical devices – New regulations – Latest updates EU: Medical devices – Topics of interest – Latest updates EU: Stakeholder dialogue – Latest update EU: Medical devices – Expert panels – Latest updates EU: EUDAMED – Latest updates EU: “Medical devices” Legislative Observatory – Latest updates EU: Research and innovation EU: Climate FAMHP: Medical device news FDA: News FDA: Medical devices FDA: Draft medical device guidance documents FDA: Recognised consensus standards – Medical devices FDA: Recently issued final medical device guidance documents FDA: CDRH Learn FDA: Guidance documents GMED: News HAS: News IMDRF: Documents IMDRF: Open consultations MD legal: Blog MedTech Europe: News Qualitiso: Blog (EN) Qualitiso: Blog articles QualityMedDev: Blog RAPS: News and articles RegDesk: Blog Health Canada: Medical devices Health Canada: Medical device announcements Swissmedic: Legal framework for medical devices Swissmedic: Medical device FAQs Swissmedic: Medical devices / Information from the European regulatory environment Swissmedic: Medical devices / News Swissmedic: Medical device regulation Team-NB: News Team-NB: Documents TGA: Articles TGA: Publications hub |
JTC 1/SC 27 – Information security, cybersecurity and privacy protection JTC 1/SC 37 – Biometrics JTC 1/SC 42 – Artificial intelligence TC 48/SC 8 – Volume measuring instruments TC 69/SC 6 – Measurement methods and results TC 106 – Dentistry TC 106/SC 1 – Filling and restorative materials TC 106/SC 2 – Prosthodontic materials TC 106/SC 3 – Terminology TC 106/SC 4 – Dental instruments TC 106/SC 6 – Dental equipment TC 106/SC 7 – Oral care products TC 106/SC 8 – Dental implants TC 106/SC 9 – Dental CAD/CAM systems TC 121/SC 1 – Breathing attachments and anaesthetic machines TC 121/SC 2 – Airways and related equipment TC 121/SC 3 – Respiratory devices and related equipment used for patient care TC 121/SC 4 – Vocabulary and semantics TC 121/SC 6 – Medical gas supply systems TC 121/SC 8 – Suction devices TC 122/SC 4 – Packaging and the environment TC 147 – Water quality TC 147/SC 1 – Terminology TC 147/SC 2 – Physical, chemical and biochemical methods TC 147/SC 3 – Radioactivity measurements TC 147/SC 4 – Microbiological methods TC 147/SC 5 – Biological methods TC 147/SC 6 – Sampling — General methods TC 150 – Implants for surgery TC 150/SC 1 – Materials TC 150/SC 2 – Cardiovascular implants and extracorporeal systems TC 150/SC 4 – Bone and joint replacements TC 150/SC 5 – Osteosynthesis and spinal devices TC 150/SC 6 – Active implants TC 150/SC 7 – Tissue-engineered medical products TC 157 – Non-systemic contraceptives and STI barrier prophylactics TC 168 – Prosthetics and orthotics TC 170 – Surgical instruments TC 172/SC 5 – Microscopes and endoscopes TC 172/SC 7 – Ophthalmic optics and instruments TC 172/SC 9 – Laser and electro-optical systems TC 173 – Assistive products TC 173/SC 1 – Wheelchairs TC 173/SC 2 – Classification and terminology TC 173/SC 3 – Aids for ostomy and incontinence TC 173/SC 7 – Assistive products for persons with sensory impairments TC 194 – Biological and clinical evaluation of medical devices TC 198 – Sterilisation of healthcare products TC 207 – Environmental management TC 207/SC 1 – Environmental management systems TC 207/SC 2 – Environmental auditing and related environmental investigations TC 207/SC 3 – Environmental labelling TC 207/SC 4 – Environmental performance evaluation TC 207/SC 5 – Life cycle assessment TC 207/SC 7 – Greenhouse gas and related activities management TC 209 – Cleanrooms and associated controlled environments TC 210 – Quality management and corresponding general aspects for products with a health purpose, including medical devices TC 212 – Medical laboratories and in vitro diagnostic systems TC 215 – Health informatics TC 215/SC 1 – Genomics informatics TC 229 – Nanotechnologies TC 261 – Additive manufacturing TC 276 – Biotechnology TC 276/SC 1 – Analytical methods TC 276/SC 2 – Microphysiological systems and organ-on-chip systems TC 323 – Circular economy TC 42 – Photography TC 76 – Transfusion, infusion and injection equipment for medical and pharmaceutical use, and blood processing equipment TC 84 – Devices for administration of medicinal products and catheters TC 91 – Surface active agents |
CEN/CLC/JTC 13 – Cybersecurity and data protection CLC/JTC 16 – Active implantable medical devices CLC/JTC 21 – Artificial intelligence CLC/JTC 3 – Quality management and corresponding general aspects for medical devices CLC/SR 101 – Electrostatics CLC/SR 23G – Appliance couplers CLC/SR 35 – Primary cells and batteries CLC/SR 96 – Transformers, reactors, power supply units and combinations thereof CLC/TC 108X – Safety of electronic equipment within the fields of audio/video, information technology and communication technology CLC/TC 210 – Electromagnetic compatibility (EMC) CLC/TC 62 – Electrical equipment in medical practice CLC/TC 66X – Safety of measuring, control and laboratory equipment List of CENELEC technical bodies SS S02 – Transfusion equipment SS S03 – Syringes TC 102 – Sterilisers and associated equipment for processing medical devices TC 140 – In vitro diagnostic medical devices TC 170 – Ophthalmic optics TC 204 – Sterilisation of medical devices TC 205 – Non-active medical devices TC 206 – Biological and clinical evaluation of medical devices TC 216 – Chemical disinfectants and antiseptics TC 230 – Water analysis TC 243 – Cleanroom technology TC 276 – Surface active agents TC 285 – Non-active surgical implants TC 293 – Assistive products and accessibility |
Public enquiries: 88 Health COS committees BNEN/M60-4 – Radiation protection in medical settings |
F.A.Q
The monitoring service is available through articles and automated tracking interfaces:
– New developments in the sector are monitored automatically
– Standards undergoing public enquiry are monitored automatically
– New standards publications are monitored automatically
– Articles summarise the latest developments in the sector
– Standards are monitored through technical committees
– Public enquiries are monitored through a standards organisation
– News is monitored through French- and English-language sector websites, including those of European and national authorities
Yes! You can request the monitoring of additional sources by email or message.