Notified Bodies Under the EU Medical Device Regulation: Avoiding Certification Delays

Notified Bodies Under the EU Medical Device Regulation: Avoiding Certification Delays

Thousands of medical device companies have until May 2020 to certify their products under the new European Union (EU) Medical Device Regulation (MDR 2017/745). And with few notified bodies approved to provide the certifications required to keep products on the market, time is running out.

Here’s the situation: Pressure from non-governmental organizations (NGOs), enforcement bodies and adverse media reports has led to a stringent rewrite of the legislation that manages the hazardous substance content of medical devices shipped into the European Economic Area (EEA). Under this regulation, all in-scope products must be recertified by official notified bodies. Once approved, companies may then apply the CE mark to their products. However, as of this writing, BSI Assurance United Kingdom (UK) is the only notified body approved to provide the certification (compared to 83 notified bodies under the former law).

Find out more about how your company can navigate the medical devices industry effectively and keep products on the market next May.

Should a no-deal scenario become a reality for the UK, EU-based companies would no longer be able to leverage BSI Assurance UK’s services. However, in such an event, the company’s Netherlands business unit may be quickly approved to provide the certification.

Many larger companies that are expected to become notified bodies don’t have the head count to manage the coming onslaught of certifications, while the smaller ones most definitely do not. Some of these smaller companies have lost their regard for the medical device industry as a profitable revenue stream. Companies that do wish to become notified bodies are subject to a long approval process, and will need to implement new systems and processes to manage their role as enforcement bodies under the new legislation.

Now, envision that there are 314,000 medical devices on the market that will need to be recertified. All of these factors combined will ultimately mean longer waits for audits, technical documentation review and certification issuance.

Furthermore, consider results from a recent study, which found that:

  • Forty-one percent of medical device companies have yet to evaluate the long-term maintenance needed to comply with the upcoming EU MDR deadline.
  • Seventy-eight percent do not have sufficient understanding of the EU MDR legislation.
  • Fifty-eight percent have no strategy in place to remediate gaps in their programs.
  • Thirty-nine percent have yet to identify, define or document compliance roles and responsibilities.

Companies that leave these tasks until the last minute may be surprised to discover the small lab that formerly provided the certification for an obscure but vital custom part has closed their doors to requests under the new legislation. Those taking a proactive approach to these requirements will be in a better position to review their existing notified body under previous EU MDR legislation such as the Directive 93/42/EEC on medical devices (EU MDD), and determine whether it will remain a viable option in the crucial year head.

Companies must perform comprehensive supplier due diligence to acquire the data and supporting documentation notified bodies need to provide the certification. In the case of over-threshold substances, companies need to provide a justification for the inclusion of the substance, with background on the product’s usage and the potential impacts of said substance.

In order to improve their chances of timely approval, companies should begin acquiring missing data as early as possible, and begin evaluating former notified bodies immediately. Other crucial steps include:

  • Establishing strong quality management systems.
  • Beginning data collection activities, including a bill of materials with accurate manufacturer names, part numbers and part descriptions.
  • Preparing to train suppliers, if necessary, about the EU MDR and the new substance list.
  • Allocating the proper time to map supplier responses and roll up data.

Managed within Assent’s Product Compliance Suite, our EU MDR Module helps companies collect and manage supply chain data to maintain market access, and reduce risk. To learn more, email