Standards | medicaldeviceslegal

Category: Standards

Standardisation request for MDR and IVDR refused; now what?

Team NB FAQ on EN62304 standard for software lifecycle processes

CE marking of apps: It Can Be Done and Here Is How

Regulating Medical Software and nothing new on the Recast

Standardisation, anyone?

ISO 14155:2011 is here: revised standards for medical devices clinical trials

New standard for medical technology used at home

Software design for medical devices

New EU competition rules on R&D, information exchange and standards

Erik Vollebregt
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Medicaldeviceslegal tweets
- MDCG 2022-14, a new position paper by the #MDCG in an attempt to remedy the issues of #notifiedbody capacity.… twitter.com/i/web/status/1… 2 weeks ago
- More on the #BlueGuide 2022: analysis of the new elements in Chapter 2 and what they mean for #medicaldevices and… twitter.com/i/web/status/1… 1 month ago
- A first look at the new(ish) things for #medicaldevices and #IVDs in the 2022 #BlueGuide #medtech #MDR #IVDR… twitter.com/i/web/status/1… 1 month ago
- Managing the 2024 MDR danger zone - and outlines of a potential solution in MDCG 2022-11 #medicaldevices #EUMDR… twitter.com/i/web/status/1… 3 months ago
- MDCG guidance as pseudo-legislation - a constitutional no-no under the #MDR and #IVDR #medicaldevices… twitter.com/i/web/status/1… 3 months ago
- Happy #IVDR day! The EU IVDR is now applicable - and what does that mean? #moleculardiagnostics #medicaldevices… twitter.com/i/web/status/1… 4 months ago
- More on the interpretation of the concept of placing on the market #EUMDR #EUIVDR #medicaldevices #CEmarking… twitter.com/i/web/status/1… 7 months ago
- Some critical remarks on inconsistencies and new requirements in MDCG 2021-27 guidance Q&A on importers and distrib… twitter.com/i/web/status/1… 9 months ago
- #IVDR amendment proposal moving on up to adoption with Council not touching the Commission's proposed text… twitter.com/i/web/status/1… 10 months ago
- Commission makes legislative proposal to manage #IVDR transition #diagnostics #IVDs #invitrodiagnostics #medtech… twitter.com/i/web/status/1… 11 months ago
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