Necessity of Compliance with EU’s Medical Device Regulation (MDR)… JNPMEDI to Provide MDR Compliance Consulting Services

The application deadline for the EU Medical Device Regulation (MDR), considered one of the largest barriers to entering the European medical device market, has been extended to December 2028, depending on the classification. This extension provides domestic medical device companies with additional time to prepare, though they still face challenges in developing solutions that meet the stringent regulatory requirements.

The European Medicines Agency (EMA), the regulatory body of the European Union (EU), announced in 2021 its reinforcement from the ‘Medical Device Directive (MDD)’ to the ‘Medical Device Regulation (MDR)’ to ensure the safety and efficacy of medical devices. Not only has the scope of application been expanded, including eyeglass frames as medical devices, but procedural complexities such as mandatory clinical trials and thorough post-market reporting have also significantly increased.

Following the regulation’s application deadline, exporting medical devices to EU member states will necessitate navigating more stringent certification processes. As a result, several global companies have declared their intention to withdraw from the European market after the announcement. For instance, Osypka AG in Germany and Gentinge in Sweden, companies specializing in catheters for infants, have indicated plans to leave the European market without obtaining MDR certification.

However, Europe is the second-largest market for medical devices after North America, with a market size reaching approximately KRW 62 trillion as of 2020. The potential benefits of overcoming these regulatory challenges are significant. Companies backed by substantial capabilities can gain recognition for their global-standard product quality and stand to gain new opportunities. The Ministry of Trade, Industry and Energy has actively supported domestic companies aiming for the international market, recently holding a meeting to share MDR acquisition strategies and encourage proactive industry response.

Despite ongoing efforts across the industry, many companies are still faced with a shortage of specialized personnel and financial constraints. Firms without an adequate global network find it particularly challenging to devise MDR compliance strategies. Therefore, companies providing MDR solutions based on strong global capabilities are becoming increasingly prominent.

JNPMEDI, a medical data platform company, offers MDR compliance consulting services based on its global capabilities in collaboration with international partners and experts. It supports companies, even those without significant overseas contacts, through a network of global partners and in-house experts. Offering tailored solutions for each medical device company based on rich global market experiences is at the core of JNPMEDI’s service.

As the first Korean company to join the Decentralized Trials & Research Alliance (DTRA) as a member and obtain platinum membership in the Clinical Data Interchange Standards Consortium (CDISC), JNPMEDI has continuously expanded its global influence since its inception. It also possesses a collaborative network with leading global Contract Research Organizations (CROs), including Avance Clinical, with whom it recently signed an MOU.

Joonhyuk (Jayden) Lim, Global Business Development Lead at JNPMEDI, stated, “Adapting to MDR regulations without international market access is practically impossible.” He added, “Since its establishment, JNPMEDI has been committed to providing services that meet international standards. With our extensive global collaboration network, we are well-positioned to outline clear MDR compliance strategies for domestic medical device companies.”