In this episode…
Renaud Anjoran is joined again by Clive Greenwood, an expert in product compliance for a new episode following on from the first episode they recorded about product compliance (which covered the main compliance challenges faced by importers).
This time they’re looking at the future of compliance standards by examining the new Medical Device Regulation (EU) 2017/745 (MDR), an extremely comprehensive and stringent regulation. They believe this ‘MDR’ signposts how future regulations will evolve and will definitely heavily impact you if you’re a medical device importer and, soon, for many other product types in all likelihood.
So, how much of a change is this regulation and how could it change what you have to go through and provide to get your products certified in future? Let’s put it this way. If you’re not 100% compliant be afraid, as the authorities are going to be coming for you in future!
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00:00 – Introduction.
01:54 – Clive introduces himself and what he does. Clive brings around 30 years of experience in the manufacturing field to the table, especially with manufacturing compliance, quality, and raising their standards, and is currently CTO at WWMG associates who specialize in standards and compliances to manufacturing industries. He has particular experience with medical device manufacturing sectors of compliance, hence today’s topic!
03:28 – What is the MDR and when did it come into effect? – The ‘Medical Device Regulation (EU) 2017/745 (MDR)’ replaces the old ‘Medical Devices Directive 93/42/EEC (MDD)’ and ‘Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)’ which were the basis for all the CE certificates on medical devices since the 90s. The MDR was published in 2017 and has just come into effect in late May 2021 (delayed to ease the importation of PPE due to the pandemic). It’s a standard that aims at closing the compliance loopholes mentioned in this episode and therefore improve the safety and quality of medical devices coming into Europe.
05:44 – If you import medical devices into the EU and have a CE certificate granted under the old MDD, when do you have to switch and will it be an easy transition? – You have 4 years from the date of issue, therefore a CE certificate issued in 2018 would need to be switched in 2022.
This will not be an easy transition.
06:42 – The Scope of the EU MDR – Wider than before, includes anything that requires the certification to ‘CE medical’ and can be used in a setting of care or for the treatment and diagnosis of patients, such as an IIR surgical mask. However, a ‘dust mask’ which is not used in a medical setting whatsoever is not covered by this standard. The old directives were vaguer on where items were to be used.
07:51 – Previously customs found it difficult to check that medical devices were certified – That’s not the case with the MDR as it’s a Europe-wide register (database) including the details of the product, supplier, importer, agent, and person who makes it available on the market. The customs officer will simply type in the number and get the full information, there’s no way to hide and they can quickly pull aside any shipments that seem suspicious.
The MDR will act as a template for other CE standards and will probably become worldwide, too.
12:39 – The MDR requires a LOT more information as technical documents before certification can be achieved –
The MDR differs from the former medical device standards because it ties together the aspects of the two QA standards (ISO 13485:2016 and ISO 9001:2015), and to be certified your QMS needs to be certified to these standards.
A common loophole is that you can get 24 samples tested and certified, and then manufacture 24 million ‘certified products.’ Not under the MDR!
To have the CE mark for medical devices you now need to supply tests data, research data, risk analysis, effectiveness analysis, manufacturing analysis, manufacturing quality control plan, and your manufacturing QC plan checklist. These form the ‘technical documents’ that need to be submitted to the accreditation/notified body (for Class II and III products).
15:37 – Notified bodies now have to take more action to monitor ongoing production after certification – They have to keep monitoring what happens in production and your historical manufacturing and market surveillance data will also need to be provided to them in the course of their regular audits on you.
16:13 – Who’s liable now (post-MDR) if there is any trouble with the products? – Traditionally the importer and, perhaps, the EU representative would be liable if, say, someone was injured by a product they’d imported and placed on the market. A loophole was that not every element of the supply chain was clear and shell companies or brokers might be importers, therefore finding someone to shoulder liability for injury or death, for instance, was often murky and difficult.
Now, under the MDR, the whole supply chain is transparent and considered for liability, starting from the manufacturer, EU representative (if the manufacturer is outside of the EU), importer, distributor, and notified body who gives out the certification (also if they are found to have provided false or fake documents). These have thorough details held in the database mentioned earlier, but must also be identified on the packaging, too.
Everyone in the supply chain should be accredited to ISO 13485 and will need to provide financial information to show that they have the ability to cover the liability they are taking. This means that PPE brokers working out of a shared office with just a couple of staff on the phone to China who made a lot of money during the early pandemic are effectively out of a job as they will not hold ISO 13485 accreditation and will probably also not be considered a legitimate operator in order to gain the certification to be a part of the medical device supply chain. Importantly, there’s no cap on liability and governments will know who to come after for any issues, so it’s in everyone’s interest to do things by the book.
20:36 – What happens if it’s found that a fake document was submitted or a problem was found? – When importing from China or Asia fake documents aren’t uncommon, test reports for example. If the market surveillance authority, EU rep, or notified body finds a fake document the notified body will immediately be informed and they and the relevant local authorities will have you remove it from the market (as extreme as having it removed from the shelves if it’s in stores or issuing a product recall which is expensive). The action you need to take may vary based on the severity of the fraudulent activity. A clinical test report would be very serious and require a recall, but if it’s a test with one or two incorrect data points it may only be required to remove it from shelves and not recall sold products. The product will not be allowed to go back on the market until the paperwork has been corrected.
This also goes for issues found with the products. The notified body will need to be immediately informed and a corrective action plan submitted before products can be returned to the market.
If this is not done you will likely lose the CE certification, and have to redo all of your compliances from scratch.
24:06 – How can companies transition from the old MDD to the new EU MDR? – Given that in the past less attention was paid to paperwork and certifications in many cases it may be impossible to transition for companies as they cannot fulfill the new requirements.
How to get compliant? They will need on staff a compliance officer with at least 4 years of experience in law, manufacturing, or quality assurance who is available to them at all times.
In the past companies would get advice from different service providers, manufacturers, maybe fudge together the right paperwork and could still gain CE certification under the old MDD, but that’s over. Many companies will have to leave the market and perhaps only established players will be able to transition.
30:08 – What if you’re planning to bring a medical device to the market soon? If you’re developing a medical device now you need to start doing the work required to get the documentation (risk analysis, manufacturing QC plan, test data, etc) now and you’ll need to get one of the few notified bodies on the list to audit and certify you (some used to be trusted and are not any longer). This might be a problem as they are said to be backed up until 2023 due to the rush to get this certification. Clive believes it will take a minimum of 6 months to get compliant.
Other geographical areas are expected to copy this standard for their own market’s medical devices and other products, so be aware that an enhanced level of scrutiny is coming.
34:43 – Why is the EU MDR beneficial? – The MDR 2017/745 is about the management of products, and gives ISO 13485 real teeth and will remove a lot of the poor quality or less safe items going into medical care settings by forcing notified bodies to be extremely diligent when certifying products (as well as making the supply chain accountable for the products). Given the need for safety when using medical devices and the wild west that cropped up around pandemic PPE which put many lives at risk, most would agree that improving the quality of medical devices on the market is a good thing. It is actually not a knee-jerk reaction to the pandemic, it was in the works years before. Clive has no doubt that people will go to court and end up in prison for non-compliance soon.
36:45 – Wrapping up.
- Read the entire Medical Device Regulation (EU) 2017/745 (EU MDR)
- We’re Buying Medical Devices From China And Are Worried Our Supplier Isn’t Legit | Disputes With Chinese Suppliers Q&A (Volume 8)
- Do Sofeast’s quality inspectors confirm that the products are fully compliant based on certificates provided by the factory?
- 11 Common Electronic Product Certification And Compliance Requirements
- Why YOU Need a Product Safety Program
- Can Sofeast help us with the certification of our new product?
- What Is Compliance Testing? [Podcast]
- US Compliance Documents When Importing from China: Q&A With an Expert
- Product Compliance 101: What Every Importer Must Know [Q&A]
We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.
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