Is CE Marking for Surgical Gowns and Drapes Mandatory for exporting to Europe?
Is the Surgical Gowns & Drapes considered under Class 1 as per MDD? (rule 1- either don’t touch patient or contact only intact Skin)
What is your view from the expert point.
Surgical Gowns and Drapes are classified as Class I as per MDD. Class I devices are considered as a low-risk device when compared to other classes. As per MDD, Non-Sterile, Non-measuring devices are exempted from notified body assessment and they are self-declared.
Surgical Gowns can also be classified as Class I sterile, so the involvement of the notified body and site audits are mandatory. So I think it is mandatory to get CE marked to exporting sterile surgical gown and drape.
Surgical gowns and drapes are classified as Class I Rule 1, unless they are sterile. This class I does not require involvement of Notified body and CE marking is by self declaration after that product could be exported to Europe.
If Surgical gowns and drapes are sterile then it would be classified under Class I sterile. CE marking requires notified body involvement for exporting to Europe.
Reference:
1. MDD 93/42/EEC, as amended by 2007/47/EC, Annexure IX
2. MEDICAL DEVICES: Guidance document- Classification of medical devices; MEDDEV 2. 4/1 Rev. 9 June 2010
The surgical gowns and surgical drapes are intended to prevent the transmission of infective agents between hospital staff and patients during surgical and other invasive procedures. They are subject to regulatory requirements and should comply with the product specific standards, such as EN 13795. And, they require CE mark to export to Europe.
The surgical gowns and surgical drapes are classified as Class I medical devices, as per MDD.
I disagree with the statement of Manoj. ” during surgical procedures”
If the same items used in surgical procedure, it must be sterile and follow NB certification for class 1s as mentioned above other bloggers
Dear Vivan,
In my previous post, I just replied to the questions and mentioned the classification as per MDD. Generally surgical gowns and surgical drapes must be sterile and in such a case, they are classified as Class I sterile medical devices. Let me know, if you need any more clarification.
As per MDR can anyone tell for surgical gown Sterile (Class 1 S) what re the various tests to be demonstrated for Sterilisation / Bio compatibility / cleanroom packing aspects along with the applicable standard references? Tx