Non-compliance with regulations can have the most devastating impact on lead times of medical device packaging and labelling. In this blog, medical device manufacturer Europlaz Technologies talks us through the most important factors in this highly-regulated market sector.
Specific requirements of shape and preservation of technical parts, as well as the necessity for cleanroom packaging and sterilisation, mean that trust in the manufacturer is essential. If there is a breakdown in communication on these elements, it can be detrimental to production.
Adhere to Market Regulations for Medical Device Packaging and Labelling
The nature of the medical device market means that the right choice of packaging and labelling is the difference between sanitation and a major potential health risk. Factors such as material choice, protection against shock and transport impact, and a trust in the manufacturer are vital in delivering a packaged product which meets stringent government demands.
As a highly-regulated market, there is limited potential for expansion and development of new entrants. However, the dynamic is changing. A swing toward plastic packaging solutions, anti-counterfeit incorporation and eco-conscious solutions are all worth considering in order to maintain a competitive edge.
Validating Your Products
The validation process for packaging includes checking package integrity, lead times, sterility and its permanence, and shelf life. Depending on the element being observed, the regulations differ. For package integrity and shelf life, the ISO 11607 standard applies. The different methods of sterilisation, however, require different sorts of regulation, affected by the product, method of sterilisation and manufacturing process. Furthermore, sterilisation audits, occurring quarterly, ensure the maintenance of these standards.
Medical Device Labelling
Medical device labelling, primarily, is for the delivery of information. The relevant legislation needs to be read before this is created, in order to ensure adherence. While marketing will play a part, the labelling allows for identification of the key information about the product, batch number, expiry date, product codes and serial numbers. Prioritising easy to understand ideas, clearly conveyed, are key. Europlaz has a range of labelling services which they can liaise with you on, to fulfil these requirements.
Top Three Elements when looking at a Medical Device Manufacturer
- Sterile cleanroom practice
- Adherence to regulation
- Trust in the manufacturer
With Europlaz, you will find all three. A wide and adaptable range of packaging options and labelling expertise supported by a highly experienced team, with extensive experience and familiarity with various regulatory systems. The option for pre-validated pouches, if your product is suitable, or the cleanroom to produce a sterile barrier, in either single or combination products.
Most importantly, Europlaz is a trustworthy manufacturer and partner. If you’d like to hear from past clients, head to our Case Studies page and find out more. Alternatively, contact us if you have any questions or to discuss your requirements.