EU Product Approval Depends on Notified Bodies

Breast implant manufacturer, Poly Implant Prothese (PIP) forced a change in the recent tone of European medical device regulations. The Medical Device Directive (MDD; 93/42/EEC) was already in revision, having undergone a significant rescript in March, 2010. Regulators were working to strengthen and improve the directive, but the PIP scandal last year illuminated serious compliance issues. Now, as a direct result of PIP, more changes are on the horizon.

The foundation of the MDD is a collection of articles (1 through 23) and annexes (I through XII). These contain regulatory requirements in support of gaining product entry into the European Union (EU). The 27-member States that comprise the EU are required to adhere with the MDD and enforce the requirements equally.

Key to the discussion of the MDD are competent authorities, the European authorized representatives, and the employment of harmonized standards. But notified bodies (NBs) will clearly have the biggest impact on a device manufacturer’s ability to have products approved. They grant use of the NB registration number to affix the CE Marking of Conformity.

Device manufacturers wishing to gain market entry into the EU, for Class I (sterile or measuring), Class IIa, IIb, or III products, need to select and contract with a notified body. Article 16 of the MDD delineates specific requirements for NBs. Because of the power an NB holds, it is extremely important to select one that you are comfortable working with. This is a long-term relationship and it should be premised on trust, with an open avenue for successful two-way communication. Why is trust so important? Device manufacturers will be sharing the intimate details of the QMS, product designs, and product safety and efficacy when device performance problems arise.

There are sources for finding NBs. The New Approach Notified and Designated Organizations (NANDO) Information System contains a listing of all approved notified bodies, information written in the Official Journal of the Commission. Currently, there are 77 NBs for the MDD. The NB audits the device manufacturer’s QMS (surveillance and certification audits) and the issuance of the QMS certificate (EN ISO 13485:2012). Additionally, the NB reviews all device applications and performs the critical review of technical files and design dossiers. It then issues the design examination certificates for Class III devices. Device manufacturers will not be permitted to affix the CE marking of Conformity onto the product packaging until the NB grants formal approval.


Bob Mehta is principal consultant of GMP ISO Expert Services, a Los Angeles/Orange County-based consulting firm specializing in global supplier quality management, supporting quality systems for FDA- and ISO-regulated companies. Mehta has more than 22 years of experience in the fields of quality, regulatory compliance, regulatory and notified body inspections, supply management, and risk management. Mehta holds MSQA, MBA, B.S. (Chem), and ASQ - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPA certifications. He serves on the committee of the Industry Board of Advisor for Medical Device Industry Education Consortium (MDIEC). He is heavily involved in remediating and implementing the risk-based quality systems and supplier audit program for Fortune 500 clients in a variety of industries, including medical device, pharmaceutical, biotech and neutraceutical. 

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