Actor registration module
As of December 01, 2020 the European Commission will make the Actor registration module available which will be the first of six EUDAMED modules.
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Brexit! The final stages?
With the previous News & Views, we highlighted that the proposed Brexit regulation mandated a UK RP, which by definition would be the importer. The latest news is that this is now obsolete!
MDR (EU) 2017/745 EN-DE Book (pdf)
It is fun to explore the legal language in practical regulatory solutions. You will find at times interesting differences or even plain mistakes working with this on a daily basis.
Swexit on hold?
On Sunday September 27, 2020, a referendum was held in Switzerland, which keeps the door open for a Mutual Recognition Agreement (MRA) between Switzerland and the EU concerning medical devices.
No CE marking needed!
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).
New and current standards have been harmonized with the current directives!
On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market devices that play a pivotal role in the current coronavirus pandemic
Standards free of charge!
CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees the light and can be used.
