Having worked in medical device research and development for over 20 years, I have contributed to many regulatory submissions for both the U.S. and European Union (EU) markets. However, now, as an EU Notified Body technical reviewer, I’ve found that there are many things I wish I had known previously to make the process more efficient.
Today’s market and regulatory environment is dramatically changing on a global scale, and success requires intense technical and regulatory preparation, knowledgeable business partners and the willingness and ability to adapt to change. Fewer people are being asked to do more in less time, especially in the start-up environment, and regulatory expertise is often specific to local regulations or is contracted outside the manufacturer.
Obtaining CE marking that allows market access to the 30 countries of the European Economic Area (EEA) can be a daunting task for a non-EU medical device manufacturer. However, guidance is available as long as a few basic aspects are understood.
Unlike the U.S., where FDA is responsible for granting device clearance or approval and postmarket enforcement, multiple institutions share this responsibility in Europe. Each of the 27 EU countries or member states (MS) transposes the Medical Device Directive 93/42/EEC (MDD) into law, and interpretations vary slightly. The EU Commission, which sits in Brussels, ensures that each of the national laws align with the MDD.
Each MS also has its own regulating body or Competent Authority (CA) that, among other functions, is responsible for approving clinical investigation plans, reviewing and approving risk analyses for devices containing animal tissue, monitoring vigilance activities and conducting postmarket enforcement. These bodies also designate and oversee other institutions such as Notified Bodies (NB) that are responsible for device and quality system certification. In addition, a European Community Representative (EC Rep) must be used by non-EU manufacturers to represent them in the EC to monitor postmarket vigilance. They also are responsible for registering EU class I devices with the CA.
A myth commonly held by U.S. manufacturers, and one that was recently presented by a manufacturer at a U.S. regulatory conference, is that regulatory clearance in the U.S. is a gateway to CE marking in the EU. While many requirements overlap, previous regulatory clearance plays no part in a certification decision. Medical devices in the EU are governed by the MDD and it is to this that all certifications are judged.
Recent changes to the MDD to incorporate the 2007/47/EC directive requirements (M5 version) went into effect on March 21, 2010. All new and existing devices must now comply with this version of the MDD, as the grace period for compliance is over. Amid its many requirements, the MDD defines device classifications (Annex IX), possible routes to certification (Annexes II – VII) and specific requirements known as Essential Requirements (ERs) found in Annex I to which conformance must be demonstrated for certification.
Classification of EU devices is generally based on the device risk level and consideration of where and how long the devices are to be used. One point often missed is that if several rules apply to the device, the strictest rules resulting in the higher classification prevail.
It is generally known that ISO Certification is required to sell medical devices in the EU, but misunderstanding persists on the differences between ISO 9001 (Quality Management Systems - Requirements), ISO 13485 (Medical Devices - Quality Management System – Requirements for Regulatory Purposes) and the CE certificates from Annex II – Annex VI. As the legal manufacturer, there is a decision on which route of conformity to choose for each classification of device.
For the lowest risk devices, self certification under Annex VII, for which no physical certificate is issued by the NB, is acceptable. For medium and moderate risk devices, certification for the quality system is acceptable. For the highest risk devices, certifications for the product and quality system are necessary.
A product specific certificate on its own is not enough. The scope of a quality system certificate is very important and should be considered carefully. It is imperative that the manufacturer ensure that the new product falls under the scope of the Annex II – Annex VI certificate before any new product is placed on the market in the EU. If unsure, this should be discussed with the NB, as scope extension may be necessary prior to adding the new devices.
Many legal manufacturers purchase aspects of the device technology or utilize subcontractors for significant portions of the design, testing or manufacturing.