Written by ForeignExchange Translations on Thursday, September 05, 2013
Our good friend Rob Packard recently published a great Medical Device CE Marking FAQs. He provides 15 frequently asked questions related to medical device CE Marking:
- What is a CE Mark, and what is its purpose? - "CE" is not an acronym. The mark indicates compliance with the essential requirements of the applicable directive. In the case of medical devices, these directives are the Medical Device Directive (http://bit.ly/M5MDD), the Active Implantable Medical Devices Directive (http://bit.ly/AIMDDirective), and the In Vitro Diagnostics Directive (http://bit.ly/currentIVDD).
- Which countries require a CE Mark for medical devices? - CE Marking is required for the EU Member States, but there are several countries outside the EU Member States that have adopted the requirements of the three device directives. The best list of applicable countries for medical devices is the contact list for competent authorities: (http://bit.ly/ContactPoints). There is also recognition of CE Certification by other countries around the world.
- What is the "new approach" to product certification in Europe? - The "old approach" involved highly detailed technical requirements. The "new approach" provided more general requirements, and standardization of requirements for safety and performance. The new approach resulted in free movement of medical devices throughout the EU Member States.
- What are the Essential Requirements for medical device CE Marking? - These are the requirements for safety and performance specified in Annex I of the three medical device directions. These directives are divided into general requirements for all devices, and requirements regarding design and construction (MDD & AIMD), or design and manufacturing (IVDD). The Essential Principles outlined for Australia and in the GHTF guidance document (http://bit.ly/EPSafetyPerf) are similar with only a few minor differences.
- What does the 4-digit number next to the CE Mark mean? – The 4-digit number is the Notified Body number. Here's a link for a list of the Notified Bodies with each of the 4-digit numbers: http://bit.ly/NBDatabase. This database can also be used to identify which Notified Bodies are able to issue CE Certificates for each type of product.
- Is ISO 9001 certification required for CE Marking of medical devices? - No. ISO 13485 is the applicable Quality Management System Standard for medical devices—not ISO 9001. However, it is not required to be ISO 13485 certified. However, ISO 13485 is harmonized with the MDD, and therefore, compliance with the MDD is presumed.
- If your company switches Notified Bodies, is product with the previous CE Mark still valid? - Yes. Once devices have already been CE Marked, the CE Mark is valid. Any new product shall be labeled with the new Notified Body (NB) number. The "grey area" is the transition of labeling when labeling stock for the previous NB number is not used up. Both NB's require a labeling transition plan from the manufacturer to outline when all inventory of the previous NB number will be used up.
- What is the "route to conformity" for medical devices? - Article 11 of the MDD defines the various conformity assessment routes for devices. The options for routes to conformity are dependent upon the device classification. The various Annexes of the MDD involved are: Annex II, III, IV, V, VI and VII.
- What is a manufacturer's Declaration of Conformity? - The Declaration of Conformity (DoC) is the manufacturer's statement of conformity with a specific assessment process. This must be in accordance with Annex II, V, VI or VII. The DoC must identify the products within a device family, legal manufacturer, conformity assessment process used, dates of validity and the DoC must be signed.
- How is medical device classification determined for CE Marking? - Annex IX defines the classification rules for Europe. There is also a guidance document (http://bit.ly/EUClassification) published that helps to explain classification rules with examples.
- How long does it take to get a CE Certificate for a medical device? - The shortest length of time that one of my client's has been able to achieve for a new CE Certificate is 14 weeks (start to certificate in hand). The actual review time was only a few weeks, but the company also needed to achieve ISO 13485 Certification. More realistic timeframes for review are 12-16 weeks for high-risk devices, but most Notified Bodies offer options for expedited reviews or dedicated on-site review of Design Dossiers and Technical Files.
- Are MEDDEVs required or optional for medical device CE Marking? - The MEDDEVs (http://bit.ly/MEDDEV) are guidance documents written by competent authorities—not law. However, MRHA has taken an active role in drafting many of these guidance documents and the Notified Bodies under MRHA's jurisdiction follow these guidance documents closely.
- Are clinical studies required for CE Marking of medical devices? - No. Clinical Evaluations are required as Essential Requirement 6a in Annex I of the MDD. However, there are two routes to performing a clinical evaluation: 1) the literature route, and 2) pre-market clinical studies. In general, Class III devices and many Class IIb devices are expected to have some clinical study data. However, if the device performance is based upon equivalence to existing devices—PMCF Studies are expected to verify the performance of the device.
- What is an Authorized Representative and can your distributor perform this function? - The Authorized Representative is the official correspondent for communication of complaints by users and patients in the EMEA, Switzerland and Turkey. A distributor may perform this function if the distributor is physically located in the EU. The roles and responsibilities of authorized representatives are defined in a MEDDEV document from 2012 (http://bit.ly/ECREPMEDDEV).
- Why do some companies have multiple CE Certificates for the same medical device? - A company will need at least two CE Certificates for all Class III devices, and depending upon the conformity assessment procedure used, Class IIb devices may also require two CE Certificates. In the case where two certificates are required, the first certificate is a CE Quality System Certificate, and the second Certificate is specific to the review of the Design Dossier for the product family. The second certificate is either an Annex II.4 (Design Examination) Certificate, or an Annex III (Type Examination) Certificate.
Also take a look at the following primers that you may have missed:
- Why IFUs need to be translated
- What is a combination product?
- MedDRA, the Medical Dictionary for Regulatory Activities
ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.