Legal & Regulatory > Turkey > Turkey: The Impact Of Brexit On CE Certificates Issued By UK Notified Bodies

The shockwaves from the UK’s exit from the European Union have resounded across the continent, including in Turkey, where the country’s pharmaceutical and medical devices regulator has had to adjust its guidance on CE-mark certified devices. Leading lawyers from top Turkish law firm and PharmaBoardroom legal partner Moroğlu Arseven explain the current situation.

CE Certificate Requirement in Turkey

The Regulation on CE Marking, published in the Official Gazette on, and effective as of, 23 February 2012 (the “Regulation”) governs the use of the CE Mark in Turkey. Medical devices covered by the Regulation must bear the CE mark to legally enter the Turkish market. Within Turkey, the CE Mark is symbolic of CE certification by a notified body authorized to conduct product conformity assessments.[1] In addition, the Customs Union Agreement between Turkey and the European Union (the “EU”), to bear a CE Mark a medical device must be CE certified by a notified body within Turkey or the EU.

TMMDA’s Response to Brexit

Upon Brexit, the United Kingdom (the “UK”) has dropped out of the EU, its notified bodies have dissolved, and CE certificates issued by them have been invalidated. Accordingly, medical devices marketed in Turkey and bearing a CE Mark pursuant to a CE certificate issued by a former UK notified body, have been decertified.

The Turkish Medicines and Medical Devices Agency (the “TMMDA”) addressed certain Brexit related CE certification matters in published announcements about a post-Brexit transition period (the “Transition Period”); within which affected devices marketed in Turkey with CE certification from a former UK notified body can become compliant.

To take advantage of the Transition Period, a medical device manufacturer, or its local representative or distributor had to, in a timely manner, file with the TMMDA a confirmation letter from the associated notified body stating that the assessment is in process; and, thereupon, the TMMDA would grant an automatic 120 day extension of CE certification during which a new CE certificate for the device had to be uploaded to the TMMDA’s online registration system.

The TMMDA has sought to minimize the impact of Brexit both on domestic consumers and global producers of medical devices marketed in Turkey.

Implementation of Post Brexit Plan

The Transition Period concluded on 31.12.2020. On 01.01.2021, all CE certifications obtained from former UK notified bodies were invalidated.

The TMMDA announced the following new post-Brexit rules for devices CE certified by a former UK notified body:

• The expiration of all CE certificates issued by former UK notified bodies, even if facially valid beyond 31.12.2020, are accelerated, and all such certifications are deemed expired as of 31.12.2020. No extension is available.
• CE certificates issued by a former UK notified body and facially valid beyond 31.12.2020, and with respect to which the 120 day extension period granted by the TMMDA has lapsed, are deemed expired as of 31.12.2020. No extension is available.
• CE certificates issued by former UK notified bodies which expired naturally on or before 31.12.2020 are deemed expired. No extension is available.

Conclusion

The global ramifications of Brexit cannot be underestimated. We have had several opportunities to communicate both with TMMDA and the TR Ministry of Health about their position on post-Brexit CE certification. Both insist on maintaining Turkey’s formal CE certification process. Nevertheless, both remain open to considering exceptional cases, substantiated by official documentation from authorized national or international authorities, where a necessary medical device not yet CE certified may require an exemption from certain regulatory requirements due, in whole or in part, to issues arising from the COVID-19 pandemic, or for other reasons deemed, in its discretion, satisfactory by the TMMDA.

[1] A notified body is an organization accredited by at least one EU Member State to conduct conformity assessments under relevant EU Directives, and based thereupon, issue CE certificates. After certification, a manufacturer may legally affix a CE Mark to the certified product.