ISO 13485:2016

The ISO13485 standard as revised is aligned more closely to 21 CFR part 820 (Quality System Regulations) and USFDA regulations. Hence, a number of minor changes to the existing standard add up to major effects and tougher quality management requirements.

As per the new directive, excerpts

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017
“The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.”

What are the changes?

There is a strong focus on risk management (medical device file, design history file – familiar from USFDA), traceability and validation processes. This is a result of the European Medical Device Regulation - (MDR) (Class 1 - 3 products), which has been in force since May 2017 and is to be further implemented in stages as follows by 2025:
Class 3 Products --> 2021
Class 2 Products --> 2023
Class 1 Products --> 2025

Rules and requirements

Following the launch of a new medical device labeling directive by the FDA (US Food and Drug Administration), most medical devices, components and instruments imported to or sold in the USA must be labeled with what is called a unique device identifier (UDI). Strict regulations apply not only in the USA.  
Similar standards were implemented in the EU, Canada, Japan and many other countries.

The US Food and Drug Administration (FDA) voted to approve the standard labeling system for medical devices (UDI) as early as 24 September 2013.

Products are designed and manufactured in such a way as to minimize risks due to substances or particles, wear and tear, degradation products, production residues and processing residues. All cleaning processes must be validated.

nopa instruments does not give a warranty on the final cleaning if the packaging is opened or damaged. nopa instruments can provide a warranty only if the packaging of the product in question remains unopened and undamaged. If the original packaging is opened or damaged, it is important to note that nopa instruments' liability ceases at this point.

ISO13485:2016 and you.

Get on the safe side - with nopa instruments

nopa instruments is one of the first surgical instrument manufacturers to have ISO13485:2016 certification. The proof is in our existing current certificates.

With us as your partner, you’re a step ahead of the competition – and waste no time implementing or changing your processes to comply with the latest ISO13485:2016 specifications.

Should you have any further questions, please contact us.

CE Marking:

• UDI code, data matrix can only be applied by lasering. Ultra-short pulsed lasers create stable and durable labeling with optimal readability across multiple sterilization cycles. The code cannot be applied by an electrochemical method.
• The instruments require cleaning and passivation after laser marking.
• The devices are packaged singly in sealed bags. The bags are perforated and contain additional product information.
• The processes involved must be validated.

As already mentioned, labeling surgical instruments by electrochemical methods (etching) is no longer allowed. The MDR also places great emphasis on the proper packaging of surgical instruments. Again, we are several steps ahead of our competition. We pay meticulous attention to clean packaging with standard-compliant labeling and identification.
We already perform data matrix code marking in line with the latest regulations for some of our customers.

If you find yourself having to meet the same requirements, please get in touch so that we can finalize the details, including the additional fee.