Should US MedTech companies be concerned about the new EU Medical Device Regulations?

The EU market has always been attractive for US MedTech companies.

Obtaining approval to sell into the EU market has in the past always been easier than getting approval to sell in the US. That may soon change in view of the new EU Medical Device Regulations.

For a long time, US manufacturers preferred to first obtain the CE mark, indicating that the device conforms to the European Medical Device Directives, then they would focus on obtaining FDA approval. The reason was simple:

  • To obtain CE mark, you had to meet the European Medical Device Directives. These directives were often easier to meet than the FDA requirements.
  • High risk devices had to be reviewed by a Notified Body. Notified Bod’s where certified by the member states and were allowed to certify conformity with requirements of the relevant MDD. Notified Bodies are private entities competing for the MedTech manufacturer’s business. They are customer oriented and time sensitive. Companies found that Notified Body’s often worked faster than the FDA.

To obtain a CE mark, a MedTech company only had to prove safety and performance, while the FDA required that a device be proven safe and efficacious. And the process to obtain a CE mark through a Notified Body was faster as well.

It has often been said that European patients had access to new higher-risk devices and procedures before their US counterparts.

In 2011 a major scandal erupted around breast implants – a French manufacturer had been using industrial silicone rather than medical silicone for its breast implants since 2001. Many f these devices had ruptured and endangered patients.

Already in 2008, the EU contemplated replacing the Medical Device Directive with new Medical Device Regulations. The 2011 scandal let the European commission to announce a “stress test” intended to strengthen the MDR’s and prevent recurrence of what had happened.

The new MDR’s were finally adopted in 2017 and will come into effect in 2020. They make obtaining certification in the EU a lot more challenging. Many analysts will say that under MDR, obtaining CE approval, will become more difficult than obtaining FDA approval.

The new EU Medical Device Regulations are expected to result in a more limited choice of Notified Bodies.

The Notified Bodies themselves are private organizations accredited by an EU country to assess the conformity of products before they are being placed on the market.

A Notified body would build expertise in a certain technology and would then be accredited to asses devices using that particular technology.

There are about 75 Notified Bodies within the EU borders, and to obtain a CE mark for its products, a US MedTech company would choose Notified Body from a list of potential candidates.

The new EU Medical Device Regulations require that all Notified Body’s be accredited under the new MDR’s before they can certify products under these new MDR’s. As accreditation of a Notified Body will become much more difficult, experts expect that as much as half of the existing NB’s will not apply for accreditation. Some Notified bodies might request accreditation for only a few of the NBOG codes.

This poses a significant problem for those companies that have been certified by an NB that is expected to lose its accreditation: when the NB loses accreditation, the CE mark certification is lost as well.

Time and Case Load Pressure

While November 26th was the first day Notified Bodies were allowed to apply for accreditation with the national authorities, most experts believe the first NB’s will receive accreditation in 2019.

Furthermore, since the new MDR’s will become effective in 2020, all CE certifications that expire after the effective date will need to be “re-issued” under the new MDR’s, adding significant workload to the now remaining smaller pool of NB’s.

Brexit and CE Certification

On January 22nd this year, the European commission issued a statement regarding Brexit. The Statement reiterates that because the United Kingdom submitted a notification to withdraw from the Union, unless a ratified withdrawal agreement stipulates another date, effective March 30, 2019, the United Kingdom will then become a ‘third country’.

In practical terms, this will mean that a Notified Body, accredited by the United Kingdom, will effectively loose accreditation for the purpose of certifying the CE mark. And, any MedTech company that obtained CE certification through a UK NB will immediately loose such certification as well.

While it is possible that a withdrawal agreement stipulating a date other than March 30, 2019 will be agreed to, companies run significant risk by not planning for the worst-case scenario.

Companies that have obtained CE Certification through a UK accredited Notified Body are therefore advised to ensure their certification is transferred to a Notified Body accredited in one of the other EU countries.

Review your Strategic Business development Plan

We urge any MedTech company to immediately review their EU Strategic Business Development plans in view of the new EU Medical Device Regulations. Any delay could result in being excluded from the EU market for a significant period of time.

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