PARIS – The CE mark is dead, long live the new CE mark.

Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the final text for the Medical Device Regulations (MDR) and IVD Regulations (IVDR), setting in motion a countdown to enforcement.

"The future is in this version and like it or not, this is what we will work with, what we need to make a success, because the alternative that it does not work is so much worse," said Ronald Boumans, the Senior Global Regulatory Consultant in The Hague, The Netherlands for the Emergo Group Inc., based in Austin, Texas.

According to Erik Vollebregt with Axon Lawyers in the Netherlands, "This is a supernova of regulation in the medical device and IVD space, a text that had exploded from 60 pages to six times that size."

They and other regulatory specialists who spoke with Medical Device Daily share a concern that there has been little industry input in shaping the regulations, that there are not sufficient resources needed to comply, that the new system may break down, and that there is not a Plan B. (Medical Device Daily, Dec. 8, 2016.)

Hammered out in a trialogue negotiation with the European Parliament and the European Commission, the text for the new legislation is expected to be approved by the Council in March 2017.

In April 2017 the Parliament is scheduled to adopt the text without amendment, which will then be published in the Official Journal of the European Union.

TIME TO COMPLY IS NIGH

The legislation will repeal the existing Directives that govern CE marking and take the force of law in May 2017. Manufacturers will have three years to comply with the MDR and five years to conform to the IVDR.

The newly released text includes technical clarifications to the compromise text released in June 2016, which were inserted during the legal-linguistic finalization by informal agreement by all Member States and the European Parliament, according to a statement by the Council.

"Considerable work has been done on inconsistencies in the text and a number of issues have been addressed since the version we saw in June," according to Lisa Boch-Andersen, Director of Communications MedTech Europe, the industry trade association based in Brussels, Belgium.

She told Medical Device Daily that examples of revisions include clarity on the transition provisions, the validity of certificates and the responsibilities of Notified Bodies – the independent companies that grant the CE mark under the decentralized system of the European Union.

"For IVDs the conformity assessments have been made more clear, and for medical devices some elements related to clinical evaluation have been clarified," she said.

Vollebregt credits MedTech Europe with negotiating the removal of an onerous provision for class IIb devices that would have required a fresh design review for active devices intended for administering or removing medicinal substances, such as insulin pumps or injectors for contrast agents.

"Now we need to work on the implementation and it will be important to have a clear plan. The Commission and the Competent Authorities from Member States are working with stakeholders to develop an implementation road map," she said

BELATED STAKEHOLDER MEETING

Boch-Andersen confirmed there will be a stakeholder meeting on March 9 in Brussels by invitation from the Commission.

Attending that meeting will be Gert Bos, the executive director at the Qserve Group, who said he expects the meeting will "explain where we are in the process, and provide high level insight into final changes, the process and expected timelines."

Bos said he hopes to express concerns in two areas at the meeting.

First, he told Medical Device Daily, "In light of harmonization and transparency, it would be extremely helpful for all stakeholders that are working on implementing the MDR requirements into their operations, if drafts of guidance, common specifications, implementing and delegated acts would be shared in early phases."

Addressing issue he finds to be in the time-critical zone of the implementation phase where manufacturers risk short notice for preparation, Bos said he would ask, "Will further guidance be readily available before the end of this year defining the approaches to decide on what 'sufficient' clinical data means, and similarly, will details of the UDI [Unique Device Identification] be clarified in the next 12 to 18 months?"

Boumans from Emergo also has been invited and will express his hope that the Commission will in some way create an opportunity for external input during the drafting of implementing acts and delegating acts, the administrative translation of the legislative intent.

"So far, industry has had limited access to the proposals and limited ways of giving feedback," he said.

"Yet the implementing acts made by the Commission are going to be vital, and there is not a formal process for the Commission to include feedback," said Boumans.

A looming problem for both manufacturer compliance and EU enforcement of the new laws is the burden for regulatory review.

"So many manufacturers will need additional clinical data, to the point that anyone walking within 100 meters of any European hospital is going to find themselves enrolled in a clinical trial. Each of these trials needs to be reviewed by a Competent Authority, yet they do not have the people," said Boumans.

"If you look at the pool of experts for regulatory affairs, where it used to be a shallow pond that was heavily fished, now there is no pond, it has dried up," he said.

"We need to think about a Plan B," Boumans said. "The transition period is very steep, and very short. There is a risk of not meeting targets in this transition. Do we have a Plan B if we encounter serious delays, if for some reason this does not work? I would seriously like to know."

SEVERE REGULATORY BOTTLENECK ON THE WAY

According to Vollebregt, the EU is headed for the mother-of-all regulatory bottlenecks.

"The competent authorities of Member States are worried about whether the EU is going to be able to make this work without encountering very big problems. They are already asking the Commission if there is a plan to make this work. They are asking how they are going to resource the system and make sure they can fulfill their obligations," he said.

Each of the roughly 55 Notified Bodies that give products the CE mark need to be re-accredited.

Vollebregt asked if this will be done on a first-come, first-served basis, or if all recertification will come at the same moment.

"If they are not all re-certified at the same moment, it matters for each manufacturer from a competitive perspective. If your company's Notified Body is on the bottom of the pile, you will be among the last to receive an MDR certification for your products. This might affect business planning."

"I am perfectly willing to go on the record to say there are already private equity firms, strategic investors and industry buyers who are on the prowl. They are making lists of potential candidates among medium-sized companies that will get caught in the bottleneck and not be able to place products on the market. This will cause cash flow problems, making the company a sitting duck for a take-over.," he said.

"How are the people in the regulatory affairs departments going to explain that the company is in trouble?" he asked.