Written by John Brosky
New European regulations covering medical devices will be final in June – just in time for the IMPLANTS 2017 conference in Paris. We spoke with the Director for Regulations and Industrial Policy at the industry association MedTech Europe in Brussels, John Brennan, about how the new rules will hit orthopedics and implant manufacturers.
- Implant card for patients
- Product classification changes
- More demanding technical and clinical files.
In June 2017 the European Union’s 30-page Medical Device Directive will be formally repealed and replaced by the 600-page Medical Device Regulation (MDR). The changes are broad and deep. For example, every medical device with a CE Mark already approved and on the market must be re-certified under the reformed laws before 2020.
Since the draft text of the MDR was released in 2016, manufacturers have been calling John Brennan, Director for Regulations and Industrial Policy at the industry association MedTech Europe in Brussels. And he said they all have the same pressing concern: What do we have to do and by when?
« The first thing for implant companies to do is to read the new product classifications, » Brennan told IMPLANTS. « More of your product portfolio may be included now than you may have thought. Products may have shifted from Class IIa to Class IIb, or from IIb to III. I know this to be true for some spine products. »
A second priority is getting a handle on requirements for an Implant Card.
« This is where we are working now with our Orthopedics work group, » he said, adding that there are exemptions and derogations and requirements for clinical investigations still to be defined. « Broadly speaking, there will be a requirement to provide an implant card. This is not completely new as there is a requirement in current practice for documentation in the patient record with a copy returned to the company so that they have an idea of who received an implant. What is new is a requirement for a card to actually be given to the patient, » Brennan said.
The law is meant to cover large implants, such as a knee or a hip, or heart valve, he said. The legislation does not intend that the patient walks away with a big deck of cards. But technically a suture, a plate and screws are implants as well.
« There are exemptions for pins and plates, yet manufacturers should look closely at the requirements for the Implant Card to see where it applies, and where there is, or is not, a requirement for clinical evidence to support the device. Manufacturers will want to take a careful look so that they do not start working where they do not need to work, » said Brennan.
Beyond zooming into issues specific to implantable devices, there are things that apply equally to all manufacturers.
« Check your files. Look to your current technical file and especially the clinical file with an eye toward remediation of those files. Do a gap analysis of what might be expected going forward. Have you been doing good post-market follow-up, which is required even today under the Directive? Is there a clinical registry that includes your products? » he asks.
Some companies have already put together clinical evidence at a level that would stand up to a scientific review and are comfortable, said Brennan.
« Anyone who is relying on a single sheet of paper that says they have sold 20 million units and only have received three complaints should know that kind of evidence does not cut it today, » he said.
Count on adding resources to comply with the new regulations.
« This needs to be someone’s job, not something someone in the company does in their spare time. Better still, it should be a dedicated team, a cross-functional team sponsored at the senior level, » he suggested.
The MDR is a major business change that affects everything from the manufacturing supply chain to how a company can market its products, he said.
Those companies that see the increased expense of compliance and the work required only as an increased cost will be the ones that struggle, said Brennan.
« Count on it as an investment in customers in Europe and to win market share. And expect a return on that investment. This is what the best-in-class companies are actively doing, » he said.
While large companies may be able to spread this investment of increased cost of compliance over a broad and diverse portfolio, for small and medium-sized businesses, the new regulations are onerous and crushing in the demand for resources.
As Ali Madani at Avicenne Medical points out, at some companies there are more employees in regulation than research and development.
Brennan agrees with the assessment, but said he would frame the question differently, asking how are medtech companies responding to the challenges in the business environment today?
« There is a huge crisis hitting the entire healthcare system, » he said. « Everywhere people are asked to do more with fewer resources. Payers are looking to pay for outcomes more than products. How can an individual business cope with this? By making sure that they have a solid value offer around products. For example, an orthopedic hospital may not need a new type of hip. What they may need is help, a solution for managing the procedure that comes from the provider of the hip implant, so that more surgeries can be performed, so that more surgery time is available to treat more patients with the same hospital resources. This may be a way of coping, of finding opportunities in services around a product as a competitive advantage. »
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