What does it mean to classify your medical device?
Classifying your MD is an essential step in the certification process because it determines the risks that your product may carry and, therefore, the regulations it must conform to in order to receive CE marking. Under the Medical Device Regulation (MDR) 2017/745, MDs fall under four classes:
- Class I
- Class IIa
- Class IIb
- Class III
These classes range from low risk to high risk, with Class I being the lowest risk and Class III the highest risk.
What is the basis of classification of MDs?
The starting point for certifying a medical device is defining the Intended Purpose of Use. The Intended Purpose will confirm whether your product is indeed a medical device (and therefore must comply with the MDR) and provide a basis for the rest of the certification process, including classification, evaluation, documentation and labeling.
How are medical devices classified?
The classification of your medical device depends on its characteristics. According to Annex IX of the MDR 2017/745, the following factors should be considered when classifying a MD:
- The period for which the MD is in continuous use
- Whether the MD is surgically invasive or not
- Whether the MD is an implant or an active device
- Whether the device contains a clearly defined medicinal substance or not
The Intended Purpose is the basis of classifying a medical device. Even if two MDs have identical technical characteristics, they can be classified differently based on their Intended Purpose of Use. Certification Experts can help to clearly define the Intended Purpose and correctly classify your medical device.
What Directives / Regulations do MDs need to meet?
The EU Medical Device Regulation 2017/745 is the legislation that MDs must adhere to in order to be sold within the EU. A two-year transition period has been in place to allow time for manufacturers to adapt to the MDR, but on May 26th, 2020, the transition period will come to an end. If you are unsure whether your technical documents comply with the new MDR, read more here.
The MDR 2017/745 will replace the following directives:
- Medical Devices Directive (93/42/EEC)
- In Vitro Diagnostic Devices Directive (98/79/EC)
- Active Implantable Medical Devices Directive (90/385/EEC)
Certification Experts also has experience certifying MDs that must comply with additional directives, such as:
- General Product Safety Directive GPS (2001/95/EC)
- Machinery Directive MD (2006/42/EC)
- Low Voltage Electrical Equipment LVD (2014/35/EU)
- Directive of Electromagnetic Compatibility EMC (2014/30/EU)
Class II and Class III MDs may require the EN/ISO 13485 Quality System certification to complete the CE process.
How to obtain the Declaration of Conformity (DoC)
We follow a five-step approach to certify your medical device:
- Step 1: Identify EU requirements for your product
- Step 2: Assess the level of conformity and perform testing when necessary
- Step 3: Compile and review the technical documentation
- Step 4: Affix the CE mark and issue the declaration of conformity
- Step 5: The product is certified and can be traded in the EU
What is the European CE Technical File or Design Dossier Compilation?
All MDs require the CE Technical file for CE marking. For Class II and Class III MDs, it is obligatory for the manufacturer/ importer to appoint a Notified Body to audit this file. A technical file includes the following information about the MD:
- Clinical Evaluation Report
What is the Clinical Evaluation Report (CER)?
The CER is an essential part of the CE Technical File. It provides strong clinical evidence that the MD achieves its Intended Purpose without posing any risk to patient lives. It is based on clinical data from the following sources:
- Existing literature
- Clinical experience
- Clinical trials
- Any combination of the above three
Who is the European Authorized Representative (AR)?
An importer or manufacturer who is not established in Europe is obligated to appoint an Authorized Representative, or AR, with a registered business in the EEA area. This is obligatory for MDs of all classes. The responsibilities of the AR include:
- Coordinating with the regulatory authority
- Keeping the updated technical documentation available for authorities at least five years after manufacture of the product
- Registering, updating, and/or notifying class I, and IVD, Medical Devices with the EEA Competent Authorities
- Assisting in incident reporting and product recalls
- Issuing of advisory notices as required