Changes To Medical Packaging Standards Under ISO 11607-1/2 | Valdamark Packaging

New EU medical device packaging regulations are due in just over a year. The new revision help medical device manufacturers conform with the new general safety and performance requirements.

The new incoming EU Medical Device Regulations are just over a year away. Check our the below advice to help medical device manufacturers conform with the new safety and performance requirements.

For those involved in Medical Device Packaging these days they have a lot of rules and regulations to abide by. There are even more on the way despite the latest revision of the ‘packaging for sterilised medical devices’ only being published last year.

This is essentially a guide for applying the rules and regulations surrounding ISO 11607. Now there is a new instalment as of February 2019.

These revisions are one of many regulatory changes that are happening around the globe. The latest revision is to help prepare companies for the new European Medical Device Regulations (EU MDR) being introduced this year.

Many of the regulatory changes taking place around the globe are based on the essential principles stated at the International Medical Device Regulators Forum (IMDRF).

The principles decided on here are published under the ISO 16142: 2016 regulations titled ‘Medical Devices – Recognised essential principles of safety and performance’. In the EU MDR they are known as the General Safety & Performance Requirements or GSPR. In the future harmonised standards will be needed to ensure conformity.

Among the requirements set in ISO 11607-1:2019 are changes to the sterile barrier packaging films and systems themselves.

Under ISO 11607-2:2019 changes include changes to validatable heat sealers as well as the assembly processes involved.

New EU MDR Requirements Effect on Registrations

The EU's new MDR regulations will require manufacturers to update their product labelling and IFUs on a global scale, with many in Asia seeing the most dramatic changes.

This is due in large part to the fact that several Asian countries rely heavily on registration certificates from European institutions — meaning that each change must be reported separately.

Manufacturers must update existing registrations not just for markets within Europe, but also for all other countries and auditing bodies outside of Europe requiring Market surveillance evidence.

Regular updates to comply with new EU MDR requirements will still be necessary — as such, manufacturers should ensure they are closely monitoring updates from European Notified Bodies and Communicating any changes immediately.

Background Information on the EU MDR
The EU's new MDR regulations will require manufacturers to update their product labelling and IFUs on a global scale, with many in Asia seeing the most dramatic changes.

This is due in large part to the fact that several Asian countries rely heavily on registration certificates from European institutions — meaning that each change must be reported separately.

Manufacturers must update existing registrations not just for markets within Europe, but also for all other countries and auditing bodies outside of Europe requiring Market surveillance evidence.

Regular updates to comply with new EU MDR requirements will still be necessary — as such, manufacturers should ensure they are closely monitoring updates from European Notified Bodies and Communicating any changes immediately.

EU MDR’S Expanded Requirements
The EU MDR's expanded requirements include the requirement for Unique Device Identification (UDI), a broadening of the definition of what constitutes a medical device, and updates to post-marketing surveillance and clinical evidence requirements.

The UDI requires each device to carry its unique identifier within each class of product with Class III products requiring it immediately, Class IIa/IIb products by May 2023, and Class I to follow two years after the labelling system is in place.

The EU MDR has expanded its definition of a medical device to encompass more types of products while concurrently reclassifying others. To meet new regulatory obligations related to clinical evidence and PMS requirements, manufacturers need to be aware that they must substantiate their claims and submit reports on identified risks or incidents.

A heightened emphasis has been placed on product safety and reliability which has led to an increase in traceability and vigilance when it comes to Adverse Events Reporting (AER). Meeting these expanded EU MDR requirements will require a significant commitment from manufacturers as they adjust their processes accordingly.

Pharmaceutical Packaging Trends To Look Out For

Below are some of the newest pharmaceutical packaging trends to look out for this year:

Nanotechnology
The increasing demand for counterfeit pharmaceuticals has become a major concern in the healthcare industry.

Counterfeit drugs, which are typically produced outside of any legal and regulatory oversight, can have serious consequences for patient safety.
Pharmaceutical manufacturers require effective packaging solutions to help prevent counterfeiting and protect customers from potentially dangerous medicines.

Fortunately, nanotechnology provides a viable solution. Also known as nanotech, this emerging technology involves printing medical-grade drug and device information directly onto product packages using unique software algorithms.

Not only does an additional layer of protection prevent counterfeiting attempts, but it also allows companies to track and trace their products - making it much more difficult for another organisation to redistribute them without detection. In addition, sophisticated security features such as holographic tags and serialised codes enhance authentication verification abilities even further.

Therefore, nanotechnology presents a powerful tool in the fight against counterfeiting and other devious activities in the pharmaceutical industry. And with the continual advancements being made in this field over recent years, it is clear that nanotech will continue to equip pharmaceuticals packaging manufacturers with the necessary tools to help thwart dubious behavior and keep consumers safe from dangerous drugs or medical devices

Smart Packaging
Smart packaging technology is revolutionising the way products are handled, stored, and delivered.

Thanks to Bluetooth, NFC, and QR codes embedded in packages, the shopping experience has become much more efficient.

These technologies allow inventory to be adjusted according to the demand for pharmaceuticals, reducing the need for extra storage space.

In addition, consumers can now monitor the temperature inside their package if it contains temperature-sensitive items.

From improved customer service to reduced costs and environmental impacts, smart packaging offers an array of benefits for both businesses and customers alike.

Accessible Packaging
Accessible packaging is an option for pharmaceuticals and devices that is becoming increasingly popular.

The goal of accessible packaging is twofold: to make drugs easier to understand, and to offer easy-to-follow instructions.

With clear and concise pictorial instructions, consumers are more likely to take medications as instructed – leading to better health outcomes overall.