So we manufacture a sterile medical device that we plan on selling globally. We package the device and gamma-sterilize it in its labeled pouch. As we would like to avoid relabeling or doing country-specific packaging, we're trying to find a way to include all labeling requirements on the pouch. So, a couple of questions:
1. When we go into the EU and UK, would we need both a CE mark and a UKCA mark on the pouch?
2. When we go into the EU and UK, would we need both the EU and UK rep name and address on the pouch
2. How does everyone handle future-proofing yourselves for new markets. I worry that putting so many symbols and names and addresses of the various authorized reps onto a pouch will introduce more risk as it will get very confusing having all that info.
1. When we go into the EU and UK, would we need both a CE mark and a UKCA mark on the pouch?
2. When we go into the EU and UK, would we need both the EU and UK rep name and address on the pouch
2. How does everyone handle future-proofing yourselves for new markets. I worry that putting so many symbols and names and addresses of the various authorized reps onto a pouch will introduce more risk as it will get very confusing having all that info.