To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.
These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.
During this spring, many experienced experts and fresh top performers have joined our team. The team of Marketing supervision and Medical services has been complemented with two new top experts. Kati Mönkkönen, Ph.D., has years of experience in the pharmaceutical industry, e.g. from Sanquin and Biogen. Her experience especially covers medical assignments. Anna Hiltunen, who […]
Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.
When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is.
IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).
The charitable exercise day will take place on 19 May.
CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.
The guide describe the essential regulatory requirements in Finland and in the EU.
Welcome Malena, Adele, Carita, Santtu-Matti, Jussi, Katri and Miika!
On March 2, 2021, the MPA has proposed to the Swedish government an increase in fees for control of medicinal products as of January 1, 2022. The reason for the increases is mentioned e.g. increase in operating costs.
The Nordic Co-operation Group has updated the Guideline on common Nordic packaging materials and the Q&A document. Four new questions have been added to the Q&A document. Some of the existing questions/answers have also been updated.