Changes to ISO 11607 parts one and two have left Medical Device Manufacturers (MDMs) wondering how new requirements will impact their business and efforts to prepare for the EU MDR. These regulatory changes add new requirements for package usability and sterile barrier systems and will use new terminology throughout the standard. With results aimed at improving care outcomes and patient safety, these changes establish consistency across global packaging and validation requirements. Here’s a rundown of what you can expect to see as these changes take effect in the coming months.
Issuing instructions: Usability requirements
Changes to ISO 11607 place greater emphasis on the importance of usability evaluations because of the key role they play in package design. New usability requirements aim to provide clinical staff with necessary instructions for use. Instructions must identify a clear location on the package to begin opening it, provide instructions on the opening technique, and describe how to present the product into the sterile field while preventing contamination or damage to the contents. Proper instructions for use are critical to infection prevention efforts and patient safety. MDMs will now be required to complete usability studies that prove the instructions are intuitive and effective.
Protecting patients: Establishing a sterile barrier system
Regulators will be looking to see that your sterile barrier system’s configuration will remain intact and prevent the possibility of microbial contamination. Your packaging should guide clinicians on how to inspect package integrity before use to ensure contents are presented aseptically. Product packaging should provide understandable steps for safe and proper use, so that the product remains sterile from the time the barrier is broken to when it’s presented into the sterile field.
Walking the talk: Standardising terminology
Although syntax may seem trivial compared to other impending changes, creating consistency in the language used across documents will help set a benchmark for global standards.
How to determine your package testing and validation needs
While ISO 11607 updates align with expectations for MDR, implementation is where the regulatory bodies diverge. Package testing will be mandatory for compliance with ISO 11607, but this is still a grey area when it comes to MDR. As it currently stands, testing is not mandatory to meet the General Safety and Performance Requirements (GSPR) with sufficient justification for safety and compliance. The reality is many legacy devices either lack this information or have undergone packaging changes that prompt retesting. Risks of non-compliance include added costs for package redesign or retesting of products, package failure, patient safety issues or having to pull a product from market altogether.
Determining your needs for package testing and validation starts with conducting a thorough gap analysis. Remember, revalidation is required if you’ve made any changes to the packaging, materials or handling processes since the last testing of the product. To achieve ISO 11607 compliance, you will need to refer to ISO 16775 to decide which tests to perform, once associated risks in your packaging have been identified. As for MDR, many legacy products currently on the market will need more documentation than most companies have available after performing a gap analysis. Because of this, both MDR and ISO 11607 will require package integrity testing, in most cases.
Securing a partner
Diligently vetting a potential Contract Research Organisation (CRO) partner is an important step to get you on the right testing path. Here’s some key things to consider:
- Expansive accelerated aging: CROs need the capability of simulating a variety of environments that the device could be exposed to over the course of its life. This capability is particularly important in testing for accurate aging information. These manipulations should consider temperature, period of time, package types and materials.
- In-house distribution testing: A CRO that can conduct complete performance validation testing in-house helps avoid hazards that can arise when multiple labs are involved.
- Environmental conditioning: Exposing packages to freezing, tropical and dry conditions supports its ability to withstand various “worst-case” scenarios. While aging testing helps establish a shelf-life, environmental conditioning ensures product stability during and after distribution.
With changes to ISO 11607 and MDR’s looming deadline on 26th May 2020, being organised and employing strategic partnerships is the way to earn regulatory approval.
From 26th May 2020 MDR will come in to effect in EU Member States. This regulation will apply to all manufacturers who are selling medical devices within Europe.
How EU MDR affects medical device manufacturers
With recent updates to ISO 10993-1 and the MDR on track to replace Europe’s current Medical Device Directive (MDD), medical device manufacturers have to develop and execute action plans for necessary testing as soon as possible. These new and updated regulations place increased emphasis on the roles that robust data and complete evaluations play in supporting medical device safety.
If manufacturers don’t pursue gap analyses, conduct required chemical characterization and biological testing, assemble submissions, and move forward with registering devices under MDR, they have two other choices. One option is to end the life of the device in Europe, and the other option is to develop the next generation under MDR and extend the current product life under MDD.
Key findings from the new KPMG/RAPS survey
A recent KPMG/RAPS survey of more than 200 medical device industry leaders found that the majority (73%) don’t anticipate they will be fully compliant with MDR by the deadline, and almost half of respondents said they will likely discontinue or withdraw devices from the market because of the regulation.
What’s most striking about the KPMG/RAPS survey is how far behind the industry is. Just over a quarter of those surveyed plan to be fully compliant by the deadline, and 46% plan to leverage MDR’s transitional provisions to continue selling in Europe through 2024, while working on their compliance programs. Additionally, 66% have yet to plan for a systematic, long-term process to remain compliant moving forward.
Organizations are investing heavily in the initial compliance efforts, with 36% estimating more than $5 million in expenditures, but few are considering how to make these efforts sustainable. With the stricter requirements of maintaining a CE mark under MDR, manufacturers must begin planning for sustainable success, if they want to continue selling their devices in Europe. As the report states: “It is possible to manage the additional workload that sustainability will require if organizations start planning now for the two to five years after application of the regulation.” This isn’t just about meeting a one-time deadline. It’s about adhering to stricter guidelines for patient safety in an ongoing capacity.
Another telling result from the survey is the recurring theme of a lack of guidance. Manufacturers are struggling to wrap their heads around the new regulations, and the clock is ticking. This is one reason it’s so important to allocate internal resources to managing MDR compliance, but now is also a great time to enlist partnerships with others in the industry that can help educate around what exactly will be audited.
Many manufacturers are hoping Europe will delay implementation – but don’t count on it! Even if manufacturers are starting late there’s still time to catch up, but they’ll have to kick it into high gear. Those that sit idle are at risk of lengthy regulatory delays, added costs, and having their devices pulled from the EU market. The May 26th 2020 deadline is fast approaching, and it’s not likely that Europe will grant an extension on MDR.
How to prepare
If manufacturers haven’t started planning for MDR, the first step is to rationalize product portfolios. A common challenge in the rationalization process is a lack of clinical experience reports, particularly for legacy products. Unearthing relevant documents presents a time-consuming obstacle, involving diving into literature or seeking input to satisfy reporting requirements. This extra work is one reason older products should be prioritized in the rationalization process. Manufacturers should also remember to focus on products that have the highest market demand and return on investment.
Before partnering with a laboratory testing facility or Contract Research Organization (CRO), it is important to assemble an internal multi-disciplinary team of specialists. Since MDR is multifaceted, the team should include experts from quality, product, regulatory affairs and engineering departments to ensure that nothing is overlooked. Together, they can conduct a gap analysis on product lines and identify any missing or outdated information in technical files. To comply with the new requirements, notified bodies will not accept historic product data or performance reviews alone which is why it’s important to do this work before approaching a testing partner.
Once all of the necessary product information and technical file data has been gathered, it is time to develop a biological evaluation test plan. Many manufacturers opt to outsource their regulatory testing needs to a CRO or lab to accelerate the process and get devices in front of regulators before competitors. Being transparent and forthcoming with details, as well as giving lab partners visibility to forecasts, intervals, and timelines will set the manufacturer and lab up for success.
Various organizations are conducting research and compiling insights in surveys, whitepapers, articles, webinars, etc. and KPMG and RAPS are great examples of industry thought leaders doing this. CROs and laboratory testing facilities are also good resources.
Not only is it important to stay on top of regulatory changes, it’s critical to understand how regulations are being interpreted by regulators. Manufacturers should choose a testing partner that spends time watching and interacting with regulators to understand their expectations on how testing is conducted. CROs or labs with international delegation on ISO committees and that collaborate with ISO by writing standards, participating in round robins, or offering other technical expertise can help manufacturers understand what regulators want on a deeper level.
The bottom line is that the industry impact of MDR is huge.