三国彩app线路登录 https:// Medical devices legal and regulatory blog Sat, 02 Nov 2019 15:13:18 +0100 hourly 1 http://wordpress.com/ 三国彩app娱乐软件 https:///2019/06/13/bottleneck-of-bottlenecks-for-notified-body-capacity/#comment-31127 Sat, 02 Nov 2019 15:13:18 +0000 http:///?p=6419#comment-31127 Came back across this entry during a search. Re-reading it, I think a key question lies here:

“we are feeling our way along in the coal mine of the new unfinished regulatory system, a cage with a bunch of dead canaries in our hand, and we have no idea if what we are doing is going to produce the regulatory approval capacity we need.”

Who is the “we” whose needs the EC is trying to meet? I think this is Question Zero. Once that question is answered, then the next question is whether the EC has the competencies needed to meet those needs.

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三国彩app网址 https:///2019/03/28/this-was-not-the-corrigendum-you-were-looking-for/#comment-31093 Tue, 29 Oct 2019 12:46:23 +0000 http:///?p=6398#comment-31093 […] There are persistent rumors that there is a second Corrigendum in the works that will be much more exciting than the first one in April this year. […]

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三国彩app娱乐软件 https:///2018/12/02/ceci-nest-pas-une-periode-de-transition-and-first-reaction-to-the-implant-files/#comment-31014 Thu, 17 Oct 2019 14:25:02 +0000 http:///?p=6314#comment-31014 […] Some Member States are getting kind of worried too. The Germans and Irish drew attention to the bottleneck recently asked for attention to this at the Employment, Social Policy, Health and Consumer Affairs Council session on 14 June 2019 in the general context of implementation of the MDR and IVDR (which, as I have blogged, is far from ideal to begin with): […]

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三国竞彩APP https:///2016/03/08/medical-devices-ma-data-protection/#comment-30957 Thu, 10 Oct 2019 07:50:07 +0000 http:///?p=2831#comment-30957 […] something less spectacular: you sell the user database in an asset transaction when divesting that service from your company (without prior data subject consent or with another GDPR compliance issue that clever people in the […]

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三国彩appapp检测 https:///2010/11/28/rohs-recast-advances-some-changes-proposed-for-medical-devices/#comment-30956 Thu, 10 Oct 2019 07:48:29 +0000 http://medicaldeviceslegal.wordpress.com/?p=57#comment-30956 […] the MDR and IVDR that devices are also covered by, such as the REACH Regulation (chemicals) and the RoHS Directive (hazardous substances). Take a look in Annex 1 of the regulation for the whole list of directives […]

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三国彩app娱乐软件 https:///2014/10/03/surprise-more-about-unannounced-audits/#comment-30831 Wed, 18 Sep 2019 04:17:45 +0000 http:///?p=2224#comment-30831 Best content which is worth reading it and useful . Thanks

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三国彩app平台网站 https:///2010/11/22/reach-is-upon-us/#comment-30617 Sun, 18 Aug 2019 14:23:29 +0000 http://medicaldeviceslegal.wordpress.com/?p=49#comment-30617 […] EU regulations and directives than the MDR and IVDR that devices are also covered by, such as the REACH Regulation (chemicals) and the RoHS Directive (hazardous substances). Take a look in Annex 1 of the […]

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三国彩app地址官网 https:///2019/07/02/prrc-guidance-under-mdr-and-ivdr-published/#comment-30593 Wed, 14 Aug 2019 15:23:53 +0000 http:///?p=6429#comment-30593 […] I decided to interview Erik Vollebregt on my podcast to make a deep dive on the changes. He wrote an article about this on his blog if interested to read […]

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三国彩app在线下载 https:///2019/07/25/e-500-per-data-subject-a-quantification-of-why-gdpr-matters/#comment-30531 Sun, 28 Jul 2019 21:50:51 +0000 http:///?p=6439#comment-30531 […] € 500 per data subject – a quantification of why GDPR matters (25 juli 2019). Medicaldeviceslega… […]

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三国彩app网址安卓 https:///2016/12/19/privacy-by-design-and-data-portability/#comment-30517 Thu, 25 Jul 2019 18:58:35 +0000 http:///?p=3968#comment-30517 […] only running our business, just getting things done – this GDPR business that starts with privacy by design just makes things way too complicated. We already have other rules to worry […]

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