The German medtech industry underscores the potentially negative impacts of the forthcoming EU Medical Device Regulation (MDR) on medtech innovation and on the provision of quality care in a timely manner in a new survey of device companies in the EU’s largest market.
Some 320 companies completed the survey, “The Effects of the MDR and IVDR on Manufacturers in Germany,” in July and August last year. It was organized by the German chamber of trade and industry (DIHK) and Spectaris, the more export-oriented of the two national medtech industry associations. IVD interests are represented only marginally, as Spectaris is a device-focused body.
The findings reveal a palpable nervousness about the business uncertainty, legal ambiguity and financial insecurity that is expected on and after the MDR comes fully into force on May 26, 2020.
Fully 75% of respondents are concerned about uncertain legal situations that will arise in the wake of the new regulations, with confusion likely over risk classifications for some product categories. Even more – 79% ̶ believe that they will have “considerable difficulties” in bringing innovative products to the market in the future. It’s not going to help the SME-dominated industry, says DIHK deputy chief executive Achim Dercks. “What our many mid-sized companies need is the confidence that they can bring their products to market in the future.”
Other findings in the survey show that 74% of companies say their own market access costs will rise, and 51% say product lines will be cut. IVD manufacturers, too, plan to cut product lines in the wake of the IVDR (in force on May 26, 2022). Elsewhere, 44% expect that R&D activity will have to be reduced, and 25% foresee a reduction in staff numbers. But the shock finding is that 35% of companies think their very existence is threatened by the MDR. One in three medtech respondents say they are worried about the additional bureaucracy impeding its ability to continue in business.
Its already been reported that many companies are looking at the need to withdraw some legacy products from the market to do heightened MDR standards.
(Also see "MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms" - Medtech Insight, 23 May, 2018.) In the latest survey, 36% of companies say they are planning to weed out some product offerings because of the future up-classification of products under the MDR. Reusable surgical instruments will be one of the categories to suffer most, now that they need to use a notified body (NB) for the first time. Another 33% of companies have yet to decide on portfolio pruning. Some 15% say the new "scrutiny" process will kick in for their products.
To lighten the burden for manufacturers, the DIHK and Spectaris have pressed for more practical transition periods, grandfathering for proven older products and special regulations for niche products, as exist in the US. The flexibility on deadlines may not be very likely, however. Spectaris’ fellow industry body BVMed toldMedtech Insightlast month that the unwarranted attention given to the industry last fall by the International Consortium of Investigative Journalists (ICIJ) had probably stiffened the resolve of the Europe Commission to be on time with its enhanced patient-safety-oriented regulations. (Also see "Medtech Under Pressure? German Industry Urges Realistic Patient Safety And Innovation Balance" - Medtech Insight, 25 Jan, 2019.)
“There are simply too few NBs in Europe to approve all future medtech applications under the MDR and IVDR,” says Achim Dercks, DIHK deputy chief executive.
Another major frustration to emerge from the survey is that more companies will have to use notified bodies for regulatory clearance, while 75% already complain about long lead times (the period between file application and receipt of CE marking), Dercks adds. “There are simply too few NBs in Europe to approve all future medtech applications under the MDR and IVDR,” he says. Thin staff resources at the NBs adds to the problems. (Also see "Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations" - Medtech Insight, 10 Jan, 2019.)
DIHK and Spectaris recommend that until sufficient elements of the supply chain are in place, including enough NBs to cover industry’s practical needs, an element of flexibility must be introduced into the MDR an IVDR transition phases. Any program to increase the number of NBs would be a sensible idea, the survey authors say. They stress that the central aim of all stakeholders should be to avoid impeding care delivery to patients.
A no-deal, hard Brexit is another potential fly in the ointment, as it could make the NBs' bottleneck even more crowded. UK NBs – representing 30% of the EU total – could find themselves outside the EU MDR process. (Also see "Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29" - Medtech Insight, 11 Feb, 2019.) Furthermore, 70% of non-EU companies entering the EU28 currently use UK NBs as their bridgehead to market entry.
Vital niche products, including pediatric products, may no longer be produced. “There is a danger that many smaller companies will experience market access problems for their products,” says Dercks. In the digital-health economy, start-ups and SMEs are already experiencing market access barriers which are having knock-on effects on their activity.
Alongside patient well being, politicians need to ensure that the industry’s competitive edge and innovation strengths are maintained, the survey suggests. Industry’s key demand is for the political support that allows industry to maintain these abilities. For that, companies say they require a reliable and predicable regulatory framework, which gives them both the freedom to innovate and the legal certainty that they need.