The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific…
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific…
…should also adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the…
…should also adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the…
…innovation”, the new European Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5, 2017. This new regulation replaces both the previous…
…innovation”, the new European Medical Device Regulation (MDR) was finally published in the Official Journal of the European Union on May 5, 2017. This new regulation replaces both the previous…
…seen a patient file an MDR. As most of the readers already know, the migration to the eMDR platform occurred in August 2015 (August 14, 2015, to be exact). Granted,…
…seen a patient file an MDR. As most of the readers already know, the migration to the eMDR platform occurred in August 2015 (August 14, 2015, to be exact). Granted,…
…be pursued Records associated with each complaint shall be retained Complaints shall be reported as a medical device report (MDR) in accordance with Part 803, when an adverse event deemed…
…be pursued Records associated with each complaint shall be retained Complaints shall be reported as a medical device report (MDR) in accordance with Part 803, when an adverse event deemed…
…to bring the NHS in line with expected changes in the EU regulatory framework. In fact, as the new Medical Device Regulations (MDR) rolls out across Europe, Unique Device Identification…
…to bring the NHS in line with expected changes in the EU regulatory framework. In fact, as the new Medical Device Regulations (MDR) rolls out across Europe, Unique Device Identification…
…Part 803 requirements (sounds like all of Part 803 – no MDR procedures) and the decision to move to a warning letter was pretty easy to make by the FDA….
…Part 803 requirements (sounds like all of Part 803 – no MDR procedures) and the decision to move to a warning letter was pretty easy to make by the FDA….
…themselves as medical device reports (MDRs), especially if patients and users are getting hurt. If an establishment racks up enough MDRs, they can expect an eventual visit from our dear…
…themselves as medical device reports (MDRs), especially if patients and users are getting hurt. If an establishment racks up enough MDRs, they can expect an eventual visit from our dear…
You may have experienced difficulty as of late in obtaining necessary regulatory approvals for the European Union market. There are many reasons for this, notably a shrinking pool of available…
You may have experienced difficulty as of late in obtaining necessary regulatory approvals for the European Union market. There are many reasons for this, notably a shrinking pool of available…
…and product malfunctions. The guidance supersedes the 2013 draft guidance, as well as the 1997 manufacturer MDR guidance document. There have been numerous changes to the medical device reporting requirements…
…and product malfunctions. The guidance supersedes the 2013 draft guidance, as well as the 1997 manufacturer MDR guidance document. There have been numerous changes to the medical device reporting requirements…
