On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market de...
New documents published by the European Commission!
We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sect...
Statement on Covid-19
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...