S
SteveK
Hi,
This is my first plunge into the forum.
On joining my company nearly a year ago, I inherited a series of Technical Files as part of the company’s MDD 93/42/EEC Class II conformity requirements for CE marking. I’ve put a lot of effort into reviewing and updating them. The previous incumbent based these; as one might expect, on published Standards (ISO, BS, EN or combination) for the particular medical device type e.g. Medical Gas Pressure Regulators. Tests etc were conducted as referenced in the Standard and reported. However, many of our products have been around for many, many years. Standards that were used have almost all been updated, merged, replaced, split up etc since the original evaluation. If they were new products, in lots of cases they would now be tested to different test specifications, limits, additional tests etc. If nothing has actually changed to the devices, in people’s opinion, should we have to retest everything to what are continuing moving goal posts? This would natuarally constitute a lot of work/resources.
Thanks.
This is my first plunge into the forum.
On joining my company nearly a year ago, I inherited a series of Technical Files as part of the company’s MDD 93/42/EEC Class II conformity requirements for CE marking. I’ve put a lot of effort into reviewing and updating them. The previous incumbent based these; as one might expect, on published Standards (ISO, BS, EN or combination) for the particular medical device type e.g. Medical Gas Pressure Regulators. Tests etc were conducted as referenced in the Standard and reported. However, many of our products have been around for many, many years. Standards that were used have almost all been updated, merged, replaced, split up etc since the original evaluation. If they were new products, in lots of cases they would now be tested to different test specifications, limits, additional tests etc. If nothing has actually changed to the devices, in people’s opinion, should we have to retest everything to what are continuing moving goal posts? This would natuarally constitute a lot of work/resources.
Thanks.