Happy Holidays, and an exciting and innovative New Year to you – and a correction
You have a lot to look forward to next year
- unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at this instructive MedCert video),
- we will or will not close the project of the medical devices regulation revision before the elections during the Greek presidency (no telling what will happen, but who knows what political deals may be sprung upon us – I hear that the Commission is planning for some very Shakespearian drama outcomes),
- after the Council meeting that was only about the medical devices revision we have no idea where the IVD revision is politically, having been moved to the political back burner or still firmly slipstreaming behind the medical devices regulation,
- then we have not even started to discuss the clinical regime in the proposed medical devices regulation, which is inconsistent with what you know about GCP from ISO 14155 on important points,
- market access will remain a point of concern, especially with reimbursement not taking any steps on EU level – why not start a parallel review directive proposal like the FDA has to compensate for the transparency directive that never got extended to medical devices?
- mHealth and eHealth markets continue to suffer from the EU’s inability to take the NO out of innovation by going carrot on the SMEs via DG Connect to then beat them down with the regulatory stick from DG SANCO – how on earth can I paper label my health app that is a medical device as an SME?
- the General Data Protection Regulation proposal will also continue to percolate through the system, and if you are planning an eHealth, mHealth, teleWhatever or other patient data intensive business, this development should be top of mind in your company, right up there with the medical devices regulation revision. This nice new law is quite hostile to consent based data health collection and processing, but with the exceptions for processing health data without consent having been trimmed down to basically nothing you can base a business model on you don’t have much choice – damned if you do, damned if you don’t. Another NO in sorely needed innovation.
- we’re sad to see him go but our multitalented support lawyer Arber is hitting the market, he’s looking for a job as in-house counsel at a medical devices company in Europe (preferably Netherlands or Belgium) so let us know if you need an excellent in-house lawyer with regulatory capabilities. We’ve already trained him for you in EU medical devices and other life sciences legal & regulatory. He already is an EU law expert with in-house legal experience and a unique skill set in languages.
And a correction
It turned out that the consolidated text we prepared for the Medical Device Regulation contained a small persistent mistake in the vigilance paragraph of the proposal where the Parliament consistently changed “serious incident” to “incident” and which we did not amend consistently.
Big thanks to Oliver Bisazza from COCIR for spotting this (and the good news is that he did not spot any other mistakes). Download your new and corrected version here or from the original blog post.
Speaking of corrections: vigilance obligations for ANY incident – that will be a LOT of extra work for the vigilance people at manufacturers.