The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect publ...
Warning – For risk class I devices!
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that...
Standards free of charge!
CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully draf...
Notified body number 11!
The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies...
Brexit Deal! Business as usual! Until when??
There are no change in business in the UK with the current Brexit Deal in place (Agreement on the withdrawal of the United Kingdom of Great Britain an...
Grace Period offered for products who lose the notified body without fault!
Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states (MS) to follow a guidance. The MHRA ...
Agenda of the MDCG and the MDCG subgroups has been released!
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Most...
For risk class I manufacturer!
Warning: No additional transition for risk class I products. Products who are risk class I and stay of risk class I must fully comply to t...
MDR deadline for risk class I Manufacturers – Ready to appoint MDSS as your MDR EC REP?
The MDR deadline for Manufacturers of risk class I products is approaching. The days until May 26, 2020 are numbered! It is fundamental that class I M...
The UK never ending story comes to an end!
We published a Brexit News & Views beginning of October for our clients to react, if needed, should a hard Brexit occur, which was on the horizon...