New postponement but no problem solution
The idea with the new MDR was primarily to increase patient safety after the scandal with industrial silicone in breast implants in 2012. As so often, the idea was good, but once again, a measure after a miscommunication has caused one to end up from one ditch to the other.
A combination of factors has meant that the imagined increased patient safety is now not at all a given, plus there are other inhibiting factors for the industry, of which the following may have the most impact.
- Many products that have been in use for several years, and even decades, must undergo a new certification, partly with extensive clinical studies. It takes time and costs large sums.
- The number of so-called notified bodies (notified bodies) that can approve the products decreased after the entry into force of the MDR. In addition to this, Brexit caused several bodies to disappear.
- There are still many uncertainties surrounding the MDR.
Unreasonable costs
The recertification of the entire product portfolio requires significantly higher personnel costs. In some cases, the costs of the approval even exceed the turnover of the products. This results in the manufacture of some medical devices having already been removed or will cease to be sold.
Children are especially affected
This is especially true in the field of pediatric surgery. Medical devices for the treatment of rare diseases and malformations in infants and young children are produced in such small numbers that the work for recertification is often no longer worthwhile for the manufacturer. For example, some products for esophageal surgery for small children are no longer available, so you have to fall back on equivalent products for adults. However, this often leads to complications. The same applies to some cannulas. In this regard, patient care is seriously threatened by the new MDR.
There are many more examples of unreasonable consequences where the patients instead of the intention to reduce it are instead exposed to a higher risk.
Research, development and production in Europe are moving
In addition to this, research and development of new products must be postponed and then their certification becomes time-consuming and costly. The director of the German medical technology association BV—Med, Dr. Marc Pierre Moell, says this:
“If more and more research and development will be relocated through emigration, we will not only lose smart employees, but also production and value creation in Europe in the future. We must therefore now work to strengthen Europe’s role again as an attractive region for investments in innovations in medical technology”.
Earlybird, a venture capital company in medical technology, previously advised its clients to first obtain the CE mark and to start selling the product in Europe and then establish themselves in, for example, the United States. Now the companies are advised to go directly to the USA or Asia; it is considered simpler and less costly.
But if the product is launched in other countries, there is also a great risk that they will be produced there and that research and development will also take place more and more there.
In Europe, so-called SMEs, small and medium-sized enterprises, are mainly affected, as their resources cannot cope with the new situation either now or in the future.
Requirements for adjustments
Small and medium-sized medical technology companies are threatened in their existence by the new regulation and future innovations are partially slowed down. Due to the lack of patient safety, manufacturers and doctors are demanding adjustments to the MDR. This concerns, for example, special provisions for medical devices with low sales figures. However, the European Commission is currently refusing to start such negotiations.
What happens now?
The new MDR has also been called a “bureaucracy monster” and a desktop product. So far, the European Commission has been fairly uninterested regarding proposed changes. Increased costs are one thing and bad enough, but when proven products are no longer available, the intention of better patient safety is countered in some cases.
Of course, it is difficult to determine what are reasonable demands, but the massive criticism indicates that the commission has largely missed the mark. Apart from various postponements, there is little indication that the structural problems with the MDR will be addressed in the near future.
Read below about the temporary relief through new postponements.
Decision on postponement
On 7 March, the European Council adopted the amendments to the Medical Devices Regulation (MDR). The European Parliament had already approved the European Commission’s proposal on February 16, 2023. The changes give medical technology manufacturers more time to transfer existing products to the MDR. This should cause a sigh of relief in the industry. But, is it really so?
For medical devices with a certificate or declaration of conformity issued before 26 May 2021, the transition period is extended as follows:
- For Class III custom implantable devices: until May 26, 2026.
- For higher-risk devices: by December 31, 2027. This includes Class III devices and Class IIb implantable products, excluding sutures, staples, dental fillings, braces, dental crowns, screws, wedges, plates, wires, pins, clips, and connectors.
- For medium and low risk products: through December 31, 2028. This includes other class IIb devices, class IIa devices and class ls, lm, lr devices.
The extension is subject to certain conditions. This means that more time is only granted for products that are safe and for which the manufacturers have already taken steps to convert to the MDR: the application must be submitted by 26 May 2024 and the agreements with the notified bodies must be ready by 26 September 2024.
The sales period for existing products previously specified in the Medical Devices Regulation Article 120(4) and the In Vitro Diagnostics Regulation (IVDR) Article 110(4) has also been abolished to ensure that medical devices already on the market can be made available also after the closing date in May.
How smaller companies (and thus AMB) are affected by the new MDR
AMB is a pure subcontractor that delivers services and polymer-based products that will contribute in various ways to improving people’s lives and well-being. AMB’s customers consist of both large international groups and so-called SMEs, i.e. small and medium-sized companies which are usually defined by the number of employees amounting to a maximum of 250 people.
Historically, it has been important – and is still important – for AMB to also be curious about new companies with growth potential. In medical technology, there are an enormous number of new product ideas that can improve people’s lives. Not infrequently, various plastic-based details are needed for new devices or parts of devices as well as protective, decorative surface treatments. But the new MDR rules now mean for many new and already established medical technology companies that even more capital and time is needed to get a product approved within the EU.
Of course, there must be rules that protect the patient, but they must be reasonable to achieve. And now there has been a vacuum for the realization of new ideas within Europe due to the new MDR. To the extent that the ideas are developed further at all, many companies choose to produce abroad right from the start, where the time from development to market is shorter and cheaper. Some development has therefore already been placed outside the EU.
During the certification period for the remaining existing products, the companies also do not have time to develop their new ideas or to improve certain products, which creates ripples in the water throughout the supply chain, which means fewer jobs and less potential patient benefit.
AMB is ready
For AMB as a manufacturing company, it does mean potentially slightly fewer requests, but on the other hand, the company has long been well equipped to be able to take care of medical technology product ideas at all.
The certification within specific ISO 13485 in combination with competent employees in project management, quality assurance and production paves the way for a fruitful dialogue with existing and new customers. A documented and proven routine for project management ensures that the requirements according to ISO 13485 for the manufacture of medical devices can be met both during the project period and then during production.
But it is still the product owner who must be responsible for compliance with the MDR for both new and old products. However, AMB will help to the best of its ability.
Welcome with your product idea, please get in touch with Robert Rudensjö eller Håkan Lavebratt.
Photo: Envato Elements (montage)
