Comprehensive approach to CE marking of Surgical Sutures

Surgical Sutures are medical devices that are used to hold body tissues together after a surgery or injury. These are used in conjunction with needles which may be varying based on their geometry such as tapered, Cutting, Reverse cutting, Trocar, Curved among others. These sutures can withstand different levels of pressure based on the USP standards.

These sutures can be made of different material such as Polyglycolic acid, Poliglactin, or natural sick, stainless steel and others. Based on the absorbency into the body and degradation they are generally classified into Absorbable and Non-absorbable sutures. Some sutures would need to withstand the tough environmental circumstances depending on the intended organ of usage.

The sizes of the sutures also are defined as per USP # 1 being the smallest, with modern sutures # 11 being used for ophthalmic surgeries. There are certain adhesives such as topical Cyanoacrylate that are used along with these sutures.

First and foremost as an initial step to CE marking of their surgical sutures the manufacturer needs to understand the classification into which their manufactured sutures fall. For Absorbable sutures fall into a class III and require additional technical file documentation while non-absorbable sutures tend to fall into the Class IIB. Also care needs to be taken into understanding the intended organ of usage as well as the material with which it is made of such as chemical composition or of animal origin such as Bovine. In cases where the suture is intended for Cardiovascular or neurological purpose it falls into a hugher risk classification.

Basically the suture manufacturers need to include documentation that comprises of the Company Details, Device description, Device features, Specimen labels, Manufacturing details, Sterilization process validation reports in compliance to ISO 11135, Clinical evaluation reports, Risk assessment as per ISO 14971 as well as a Biocompatibility report and a stability report to conform the stability of the device as a part of their CE technical file as a part of the Conformity assessment for CE marking. Additional care also needs to be taken to comply to the applicable Harmonised Standards that are applicable to the device.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jr@i3cglobal.com

Jeyadevi Rajesh is a regulatory specialist at I 3 Consulting, a leading firm specialising in CE and Fda submssions. Contact jr@i3c.com for further information.