The new Medical device regulation
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.
Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow.
As a global industry leader, we are committed to sharing best practice by providing easy access to information that helps our customers stay up to date on the latest changes to standards, current industry trends, as well as forward-looking resources that can help you prepare for what lies ahead.
Our resources cover everything from the services we provide including the medical devices we support to customer case studies and links to key medical device professional and trade associations.
TÜV SUD medical devices and IVD:
For over 30 years, TÜV SÜD has provided market access solutions and regulatory expertise for manufacturers and suppliers of medical devices and in-vitro diagnostics. Our services put your product through its paces and ensure medical device market approval and acceptance.
We have in-depth knowledge of the medical devices and IVD market and our dedicated team of over 700 experts, engineers, and medical doctors provide assessments that cover the full life cycle of your products. We are global, multilingual and have experts in all major markets who provide tailored advice for ensuring your medical devices are approved and accepted. Read more about our testing services for medical devices and IVD equipment below.
Johner Institute Medical Device Regulation:
Short descriptions on different aspect of MDR.
Dansk
Lægemiddelstyrrelsen(især dansk, lidt på engelsk):
Lægemiddelstyrelsens opgave er at føre tilsyn med de bemyndigede organer og at reagere, hvis vi får kendskab til sikkerhedsproblemer med specifikke typer medicinsk udstyr. Det gør vi blandt andet ved at reagere på relevante indberetninger om hændelser med medicinsk udstyr, som vi modtager fra virksomheder, sundhedsprofessionelle eller borgere.
Overbliks beskrivelser af godkendelse og formular til indberetninger.
Medicoindustriens kurser og seminarer er åbne for alle. Kurser og seminarer udvikles i tæt samarbejde med Medicoindustriens ekspertgrupper og medlemsvirksomheder.
Mange kurser i de forskellige emner i MDR.
WelfareTech webinar-serie: Knæk koden til det regulatoriske område(MDR):
Den 26. maj 2020 holdes den første seance i vores webinar-serie om det regulative område. Her kan du høre oplægsholdere Dorthe Wallin fra Cortex og Peter T. Løkke fra Serini fortælle om Medical Device Regulations, i daglig tale MDR.
Læs mere om de kommende seancer i webinar-serien:
- 27/5-2020, kl. 10:00: ISO 13485 – Kvalitetsstyringssystemer
Oplægsholdere: Dorthe Wallin, Cortex, Peter T. Løkke, Serini. Læs mere her. - 28/5-2020, kl. 10:00:ISO 14971 – Risiko ManagementOplægsholder: Morten Fjordbak, Cortex. Læs mere her.
- 2/6-2020, kl. 14:00: ISO 141555 – Klinisk Evaluering
Oplægsholder: Morten Fjordbak, Cortex. Læs mere her. - 4/6-2020, kl. 10:00: Medicinsk Software og EN62304Oplægsholder: Claus Lindholt, Mermaid Care. Læs mere her.
