Andreas Aichinger MSc is an independent auditor for medical technology. He speaks to us about the impacts of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) on manufacturers and distributors, focusing on how they relate to translations and the ISO 13485 standard.
Please tell us a little bit about yourself, your professional career and what you do right now.
My name is Andreas Aichinger. I trained as a chemist, and I began my professional career working in the central analysis laboratory at a pharmaceutical manufacturer. I then went into production, and in my role as the GMP Officer [Good Manufacturing Practice] I was responsible for ensuring we met a wide range of quality management requirements across the chain from the supplier to the customer. After 13 years in pharmaceuticals, I joined an international manufacturer of medical products and IVDs, where I was in charge of global quality management for seven sites around the world. For the last four years I’ve worked as an independent auditor for medical technology (ISO 13485, MDR, IVDR), and during this time I’ve had a strong focus on the new European regulations for medical devices and in-vitro diagnostics – in fact, I wrote a book about them.
Was this the job you always wanted to do? What for you is the most interesting aspect of your work?
Not at first, as I tended to picture myself working in a laboratory. But as I my career progressed, I realized that my knowledge and experience could benefit other businesses if I offered them professional auditing services. I have a kind of bird’s-eye view when it comes to my interest in quality management, and I think that’s how you have to look at it. As a Quality Manager, for example, you’re responsible for all the areas and processes involved in the value chain at a business – no one else, apart from the senior managers, has that overarching perspective on the business as a whole. That’s what attracts me to it, and in recent years there’s been a huge increase in the range of products and requirements, plus more businesses that I’m responsible for. It makes my job incredibly stimulating.
Where do the majority of your clients come from? Are they manufacturers or distributors? Or suppliers/stakeholders (like MEINRAD)?
My clients come from various sectors, and they include manufacturers, distributors, retailers, suppliers, and medical technology service providers. Because although the original version of ISO 13485 only applied to manufacturers, the major revision in 2016 expanded its scope to all stakeholders in the chain.
What do you think has changed since last year with the MDR? What are the main differences between the MDD and MDR process?
The MDR was published in 2017, with the transition period running until May 2021, to ensure the regulations kept up to date with the latest technology. I think that was necessary, particularly because the last revision of the old Medical Device Directive was in 2007. One main difference is definitely the addition of distributors as stakeholders, with corresponding obligations. And products were added to the MDR’s scope which in themselves don’t have any medical purpose, such as cosmetic contact lenses. That means these products are now subject to the full regulatory requirements for medical devices.
A key aspect of the MDR is explaining the functional performance and safety of each medical device across its life cycle. So at regular intervals manufacturers must produce reports on clinical safety and performance for authorities and notified bodies, in order to evaluate and take into account the findings and experiences with their medical devices on the market. The regulations on technical documentation in Annex II and Annex III of the MDR are one positive aspect. Unlike the old MDD, for the first time they clearly specify the contents and structure for technical documentation. Given that every third incident involving medical devices is caused by them being unfit for purpose, it’s good that the new regulations make fitness for purpose a high priority and require manufacturers to actively monitor the market.
What’s the reason for that? Is it down to poor-quality user information, i.e. the product documentation or its translation?
The statistics don’t show it, but fitness for purpose clearly depends on the documentation that accompanies a product – labels, information on the product, software etc. – and the translation of this documentation into other languages.
Has the MDR had any negative impacts?
Yes, there are negative aspects too. The notified bodies were reorganized, and some of them lost their MDD accreditation and had to apply all over again for MDR accreditation. That has resulted in a shortage of notified bodies, as not all of the MDD bodies applied for or received MDR accreditation. And the requirements for notified bodies, specified in their own Annex VII of the MDR, were made much more stringent. To give you some idea of the situation now, there used to be 60 notified bodies in Europe – now there are half as many. So even if a manufacturer can find a suitable notified body, it currently takes at least six months to get a conformity assessment.
What’s the situation with the In Vitro Diagnostic Device Regulation (IVDR) – have there been similar developments?
Yes. The classification system has been modified, and new criteria are used to classify the risk of devices. The old regulation was from 1998, when the devices were divided by purpose into three risk categories: List A, List B and “Other Devices”. The IVDR now has four risk categories, A, B, C and D. Previously around 80% of devices were classified as low-risk (so there was no need to get a notified body involved), but now it’s the other way round: 80% of devices are in a risk class which requires testing by a notified body. As you can imagine, that has put a lot of pressure on manufacturers. Following the introduction of the IVDR, there are currently only seven notified bodies in the whole of Europe.
What are the most visible impacts of the new MDR and the new IVDR for medical device manufacturers and their stakeholders?
Manufacturers of medical products and IVDs previously focused heavily on technology and functionality, but since the MDR was introduced, the medical and clinical aspects of their products now have clear priority. As a result, manufacturers are having to find experts in these areas and are employing more medical and clinical specialists to ensure they meet the requirements. Unfortunately, another visible impact is the shortage of notified bodies I mentioned earlier. Manufacturers of products in certain risk categories rely on these notified bodies: if they can’t find a notified body, they can’t get a conformity assessment, and they can’t launch their product on the market. Ultimately, this shortage of notified bodies will lead to manufacturers bringing out fewer new and innovative products, and sadly some good, established medical devices may have to be withdrawn from the market in future.
The content has to adapt to the changing legal and regulatory requirements in the various markets, the new expectations and the constant progress of innovation. What do you think are the major challenges for medical device manufacturers?
Even if the new regulations help us achieve a largely harmonized framework at a European level, in terms of global harmonization there’s a long way to go! Almost every country has its own regulations for medical devices and in-vitro diagnostics. That’s a challenge for businesses operating internationally, and even more so when these regulations are constantly changing and manufacturers have to adjust to these changes.
What does the MDR specify for manufacturers when it comes to translations?
We have a variety of languages in Europe. The MDR leaves it up to the Member States of the EU to decide which language the documentation needs to be translated into in order to sell a device in each country. User instructions are the first things that spring to mind here, but it also includes all information related to the product: labels, product catalogues, brochures, websites, training documents and much more. Translators are critical suppliers in the chain, as their translations have a direct influence on the safety and fitness for purpose of the device. So translators and translation agencies need to meet certain requirements and be monitored for the risk their services pose.
Are certifications for the translation industry or ISO 13485 a reliable indicator that a translation agency is a suitable, high-quality service provider for life sciences?
Absolutely! ISO 13485 certification means that once a year an accredited certification body audits the workflows and processes at a service provider to ensure they comply with the standard. If a translation service provider has this ISO 13485 certification from an accredited body, they’re a better place to go when translations are required. The quality certificate will have a corresponding accreditation symbol or endorsement to indicate that the service provider meets these quality standards.
What are the benefits of an ISO 13485 certified translation service provider?
A translation service provider is a critical supplier, as their services – e.g. translating user instructions or specific user safety information – can have a direct impact on the safety and fitness for purpose of the medical device. So manufacturers must evaluate and monitor the service provider and their services. A translation must always be reviewed by the manufacturer as part of their quality management system. Having an ISO 13485 certified service provider for their translations hugely reduces the extent to which a manufacturer needs to monitor their supplier: a large chunk of their work has already been done by a certification body, and they can focus on their own product requirements when carrying out audits. That offers added value for any medical device manufacturer. The manufacturer or the distributor is always responsible for monitoring critical suppliers, and this is a lot simpler if the translation agency is ISO 13485 certified. The extent to which the translation service provider must be monitored depends on the risk and a range of other factors, such as the level of risk in the documents and whether the manufacturer is able to check the agency’s output, e.g. using native-speaker members of staff.
Do you think the MDR and ISO 13485 go hand in hand?
In terms of system requirements, their demands are similar, though the MDR and IVDR focus solely on the medical performance and safety of the devices. You need ISO 13485 to meet the MDR/IVDR requirements in a real-world quality management system, as neither the MDR nor the IDVR contain enough information to establish a quality management system. Without the ISO standard, you won’t have enough information about the individual requirements and how they are met.
Would you agree if we said that manufacturers should bear the potential internationalization process (i.e. the translation) in mind from the moment they start producing the product information and documentation? Where would you start in order to make sure the translation process doesn’t become an afterthought?
Yes. The target markets and their demands are part of the product requirements, and these must be defined before a manufacturer begins developing a new device. Another important element is the risk assessment for the medical device – as early as possible in the project, this should include evaluating the risks arising from poor-quality translations of all the information provided by the manufacturer and identifying how the risks can be minimized in order to reduce the impacts of these risks to an acceptable level.
Finally, let’s look at the role of distributors in particular. Distributors who deliver translations aren’t treated as the manufacturer. What do people need to bear in mind?
Distributors can now handle translations without having to take on the role of the manufacturer. Previously, distributors were reluctant to change the product in any way. If the translation is handled by the distributor, it must be legally required for the country in question and it must be produced within the framework of a quality management system. Again, working with an ISO 13485 certified translation agency means that although the manufacturer still needs to evaluate and monitor the agency, this supplier audit is a lot less complicated.
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