(Scroll down to the bottom to see updates as they happen)
Words like Patient-Oriented Innovation sound good. Let’s see what that means in the workding of the text. Does it really point to safer, more effective and innovative medical devices?… or less incentive to innovate because of a raised regulatory bar?
From the press release , main elements of the proposals include:
- Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified for instance, as regards medical software. This will ensure that the safety and performance of these products are correctly assessed before they are placed on the European market;
- Stronger supervision of independent assessment bodies by national authorities;
- More powers and obligations for assessment bodies, to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing;
- Clearer rights and responsibilities for manufacturers, importers and distributors, applying also to diagnostic services and internet sales;
- Extended database on medical devices, providing comprehensive and public information on products available on the EU market. Patients, healthcare professionals and the public at large will have access to the key data concerning medical devices available in Europe, allowing them to make better informed decisions;
- Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns. A Unique Device Identification system will be introduced to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting;
- Stricter requirements for clinical evidence, to ensure patient and consumer safety;
- Adaptation of the rules to technological and scientific progress, for example the adaptation of the safety and performance requirements applicable to new health technologies, such as software or nanomaterials used in healthcare;
- Better coordination between national surveillance authorities, to ensure that only safe devices are available on the European market;
- Alignment to international guidelines, to facilitate international trade.
No surprises in there? Greater transparency, stronger supervision of notified bodies, stricter rules on evidence, better powers for monitoring, including unannounced site visits.
Unique device identification to be implemented gradually and proportionate to the risk class of the device
Registration of manufacturers and devices on a European database.
Oh OK here we go
New legal framework focuses on patient safety
Shock about recent breast implants
Devices can flourish in Europe, but citizens must be fully confident
pre and post market control main focus
extended to implants and clarified for diagnostics
role of distributors clarified
clinical evidence tightened with continuous monitoring
notified bodies more competent and independent… duty to make unannounced inspections
checks on marketed products by competent authorities
database of products on market
now the questions:
premarket testing requirements clarified?
Not going for PMA process but scrutiny panel that would monitor NB authorisations as they come along. Panel informed of high risk device plans before authorisation is granted.
On PIP case, distances regulators from what is a “fraud”. In-market controls would have picked it up, which are being strengthened.
Q: info for device users?
A: one common database across member states, accessible to general public incl professionals. Data protection dealt with as is commercially sensitive information. Stronger presence of competent authorities. They should verify the capabilities of notified bodies. Comp authorities also take part in in-market controls… and make sure info on every product in database is available.
Q: German TV asked if new rules endanger “test patients”
A: New rules will ensure safety and bring back full confidence in patients. 400 day PMA time is to be avoided, as is bureaucracy of management of 500,000 devices.
Q: How will new rules prevent fraud like PIP… sorry that bit’s in French, best I can do
A: New proposals would militate against fraud…. company didn’t hide devices but made according to wrong specs… two measures… in market controls by comp authorities and NBs. PIP would have been detected and eliminated earlier. non notified inspections will also be mandatory.
Q: Supervision and on site inspections… national comp authorities or European element?
A: Pan European scrutinisation will level capabilities across Europe as will central database.
Q: Credibility of European panels
A: Experts will be nominated by each member state. Scrutiny standards will be introduced.
Q: How will all extra testing be financed?
A: Fees will be paid to authorising bodies to ensure they make proper authorisation… (ed:so presumably companies will pay more and prices will go up)
That’s all folks….