UPDATE : Friday, June 5, 2020
Brexit to take toll on Korean medical device makers‘Glitches in certifications by UK-based operators could hit exports of over 150 companies’
  • By Park Gi-taek
  • Published 2019.04.16 16:18
  • Updated 2019.04.16 16:18
  • comments 0

“We are seriously concerned about no-deal Brexit. In the worst scenario, it could prevent more than 150 companies from exporting products to Europe, which could generate 250 billion won ($220.1 million) in losses.”

Lee Jai-wha, chairman of the Korea Medical Devices Industrial Cooperative Association (KMDICA), speaks in a recent interview with Korea Biomedical Review.

The laments came from Lee Jai-wha, chairman of the Korea Medical Devices Industrial Cooperative Association (KMDICA), in a recent interview with Korea Biomedical Review. He said the manufacturers are worried about how the U.K.’s withdrawal from the European Union will impact their business.

To export medical devices to EU, Korean manufacturers should obtain CE (Communaut European) Certification, an integrated standard proving that the product meets requirements for safety, health, environment, and consumer protection.

To date, the manufacturers have received CE certification via EU Notified Bodies, including British ones. If the U.K. pulls out from the EU, however, CE certification issued by U.K. Notified Bodies becomes invalid.

“On withdrawal, CE certification issued by U.K. Notified Bodies cannot be used in Europe. This poses a risk that Korean exports to Europe could plummet,” Lee said.

Although the deadline of the Brexit was extended for six months until Oct. 31, local medical device companies are still agonizing over how to cope with the risk, he said.

“There are two U.K. Notified Bodies that Korean medical device companies received CE certifications. One is operating another body in the Netherlands in preparation for Brexit, but the other is not having a clear policy,” Lee went on to say.

He noted that the other body issued certifications for about 150 Korean companies, which exported about 250 billion won worth goods to Europe as of 2017.

To solve the problem, the U.K. Notified Body could change its location of the head office to another EU country. Another method is that the EU recognizes the certification issued by U.K. Notified Bodies.

However, the issue is beyond the control of Korean companies. They could switch to another Notified Body to seek certification, but it will take a long time as well as much cost.

“Europe has high entry barriers. Even if a company gets certification after long time preparation, it’s not the end of the story. It still has to receive inspections and post monitoring. To prepare for this, it takes much workforce and cost,” Lee said.

KMDICA is searching for ways to relieve concerns over the uncertain certification issue.

Lee recently requested for the Korean government to ask the European Commission to give a grace period for Korean exporters so that they can continue supplying products to Europe via getting certified from other certification-issuing institutions.

“Through the Ministry of Industry, Trade and Energy, we will push for the request for the European Commission and keep monitoring information about Brexit for our members,” Lee added.


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