CE Certification is vital for any products sold in the EU. In order to keep it, you need to follow the essential requirments outlined in the Medical Device Directive.

April 16, 2013

3 Min Read
Essential Requirements Can Make or Break CE Certification

Complying with essential requirements can be a daunting task for device manufacturers. After all, if a device manufacturer wants to introduce a medical device in the European Union (EU), it should be safe and effective for its intended use. It isn’t supposed to hurt the patient of the user. So how difficult can that be?

Demonstrating conformity with essential requirements is a fundamental necessity of the EU’s Medical Device Directive in order to maintain a CE mark. If the device manufacturer is employing harmonized standards for testing and the evaluation of medical devices, then member states presume that compliance with essential requirements have been achieved.

However, complying with them is a bit more complex than just claiming it with harmonized standards. All claims must be supported by objective evidence, and multiple elements associated with establishing compliance with essential requirements need to be considered. This includes:

  • Product risk needs to be reduced to the lowest possible level.

  • Robust design and development practices should be pursued with state-of-the-art technologies.

  • Devices must be manufactured and packaged to ensure the device remains safe and effective for its intended use.

  • A clinical evaluation is required to demonstrate conformity with essential requirements.

  • Materials must be acceptable for human use and pass biocompatibility testing, if needed.

  • Devices should prevent infection and microbial contamination.

  • Devices need to be designed and manufactured to prevent injury due to radiation, electrical shock, or mechanical failure.

  • Devices must be properly labeled, including accurate instructions for use that contains sufficient safety directions for using the device. Each member state retains the legal right to have product labeling and instructions for use in their native tongue.

  • Product labeling needs to contain specific pieces of information, including: (a) manufacturer name; (b) lot number; (c) product sterility method; (d) shelf-life information; (e) reuse information; (f) storage conditions, (g) warning/precautionary statements; and (h) the CE marking of conformity.

Don’t forget to assemble an essential requirements checklist: A compiled list of all standards (harmonized and non-harmonized); manufacturer-specific procedures, protocols, and reports; and other relevant documentation that supports product conformity to the essential requirements.

Failure to establish conformity will impact a device manufacturer’s ability to retain a CE mark on their product packaging. If the notified body identifies conformity issues during the initial review of a technical file (Class IIa & IIb devices) or design dossier (Class III devices), there will be a delay in receiving initial device application approvals. If issues with sustaining conformity are noted in products, the notified body can force the removal of the CE mark — and no CE mark means no revenue from the EU.

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.

Related Articles:

Three Essential Elements to Comply with the EU’s MDD

Wrongly Affixing a CE Mark Could Be a Costly Mistake

EU Product Approval Depends on Notified Bodies

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like