No one in Europe is celebrating. Though April 5, 2017 was called "an historic day for our industry" by the German Medical Association BVMed, based in Berlin, before it carefully described a potential train wreck the new legislation has put in motion. (See Medical Device Daily, Feb. 27, 2017.)
And the trade association MedTech Europe offered a warm welcome on the part of industry before cautiously calling for greater clarity and pleading for early stakeholder involvement in developing the governance structure.
The final, formal act required for the separate IVDR and MDR legislations is publication in the EU's Official Journal, which is expected in early May. Exactly 20 days from that publication the clock begins ticking on a three-year transition period for compliance by manufacturers with MDR and a five-year transition for makers of IVDs.
"A lot of work has gone into these regulations and there is still a lot to do to make them a reality," said Serge Bernasconi, CEO of MedTech Europe in a statement. "The amount of effort needed from all parties to implement these revised rules cannot be underestimated. Essential elements, like Notified Body availability to handle the new requirements, should be dealt with outmost urgency." (See Medical Device Daily, Dec. 8, 2016.)
NO GRANDFATHERING OF PRODUCTS
The new laws make no provision for grandfathering of products already on the market.
Every medical device sold in Europe, and a whole new class of nonmedical devices, such as cosmetic lasers, must be recertified, or certified for the first time before June 1, 2020.
The impact is even greater for IVDs. Under the former EU directives, 80 percent of diagnostic were self-certified by the manufacturer. Now all devices must undergo scrutiny by a Notified Body, and there is no grace period granted for self-certified devices.
IVDs manufacturers will also need to produce clinical evidence with their certification submission, something few companies have compiled on their devices.
MedTech Europe devoted special attention to this area, stating, "For the in vitro diagnostics sector, this is a major overhaul of the rules. While, in the large part, the new text brings Europe in line with international regulatory norms in this area, there is still the need for all parties to work together on the needed secondary legislation and European best practice guidance in order to meet the transition deadline. Industry has already pointed to several priority areas including classification, conformity assessment, clinical evidence and the early availability of notified bodies."
Going forward, Bernasconi cautions in the association statement, "A successful implementation of the regulations will be a key priority. A clear roadmap is important to ensure that all players – authorities, notified bodies and economic operators – can successfully transition to the new regulations."
CONVERGENCE OF CONFLICTING REQUIREMENTS
BVMed was in the process of sending out its regular newsletter, MedInsight when news of the long-awaited passage of the new regulations by Parliament came through.
In that issue the association highlights for its members the convergence of conflicting requirements in the new law. On one hand, it points out, there is the requirement that every manufacturer renew the certification for every product, and then concurrently the EU requires the review and renewal of certification for the Notified Bodies that award the CE Mark under the EU's decentralized regulatory system.
Yet Noti?ed Bodies cannot undergo recertification until, at the earliest, six months after the new law has entered into force, which BVMed notes cuts short the actual transitional period for manufacturers.
Renotification of Notified Bodies will take at least another 12 months, which means that only from 2019 manufacturers will be able to submit their applications for recerti?cation to the newly renotified Noti?ed Body.
"By the time all the manufacturers in the EU and third countries have been recerti?ed, the three-year transitional period will have long passed," BVMed stated.
"In light of this unfortunate situation, manufacturers are well advised to renew their old certificates shortly before the end of the three-year transitional period as these will then be valid for up to four more years after the date of application of the MDR," the association concluded.
Medical Device Daily spoke with two expert consultants on the front line of EU regulation with manufacturers who also participated in closed-door sessions in the run-up to the trialogue negotiations between the Parliament, the European Council and the European Commission that hammered out the final text.
According to Ronald Boumans, senior global regulatory consultant in The Hague, The Netherlands for the Emergo Group Inc, based in Austin, Texas, "The new rules are very detailed, and because they are now legislation, there is no room to play around. When the law states you must do something, you must do exactly that even where it is not logical."
Companies may have become complacent with compliance under the EU directives that gave more leeway thanks to guidance documents. That flexibility ended with passage of the new laws, he said.
The imminent passage of the law has recently stirred what he called a "dynamic in the market where for the first time companies are worried about how to approach recertification and the status of their portfolio of products."
There can be only three strategies to the recertification of products, he said, which are to go early, to go late, or to run down the middle, and there are risks to each choice.
According to Erik Vollebregt with Axon Lawyers in the Netherlands, "Companies that have been sticking their head in the sand so far had better start working to avoid ending up without an MDR certificate when the transitional period ends summer 2020."
Med-tech companies may be betting on slipping through a four-year grace period for compliance provided in the law. IVD makers are given a two-year grace period.
There is a subtle change to the text in the final law that now makes this option much less attractive, he said.
"Once the certificate expires in 2020, no significant design change to the product or intended purpose changes are allowed anymore. This is crucial for manufacturers, as it will affect their competitive position in the market. If they are late and don't obtain a renewed certificate during the transitional period, and if they are lucky enough to be able to extend the existing certificate past the date of application, all device innovation is essentially frozen until the Notified Body gets around to issuing their certificate"