Medical Software Devices – The Most Effective Path to Certification

Vladimir Burgic, Quality Manager at HTEC Group

The CE marking process is obligatory if you want to put your product on the EU market, but can also help with the Australian and New Zealand markets. Russia has a similar but different approach, while for the US market you have to get an FDA approval.

European Union (CE Marking)

European Union has a set of directives and regulations under the so-called New Approach. These directives provide requirements that the manufacturer must meet to put a CE mark on the product. Products with a CE mark can be sold on the EU market without restrictions.

There are three directives covering the field of medical devices: MDD 93/42/EEC for general medical devices (which range from syringes to life support systems), AIMDD 90/385/EEC for active implantable medical devices (e.g., pacemakers) and IVDD 98/79/EC for in vitro diagnostic devices (e.g., various biochemical tests from blood or urine). Product-specific harmonized standards are standards that define requirements for one specific product category.

These directives will be replaced with new regulations: MDD and AIMDD with MDR 2017/745/EU, and IVDD with IVDR 2017/745/EU.

All the documents actually rely on a set of “harmonized standards.” The manufacturer must determine which standards apply to the product, and then demonstrate the compliance of the product with the standard. The standards can be divided roughly into two categories – general and product-specific standards.

First and foremost general standard is EN ISO 13485:2016 (Medical Devices – Quality Management Systems – Requirements for regulatory purposes). It gives the requirements for the overall documentation and management system in the company.

The second is EN ISO 14971:2012, risk management requirements. The manufacturer must determine and assess risks posed by the medical device, and reduce these risks to a minimum.

Further general standards are not so general but still apply to a wide range of products:

• EN ISO 10993 family of standards provide requirements for proving biocompatibility of medical devices that are in direct contact with the patient
• There are several different standards for different sterilization methods. If the device is sterile, one of these standards will apply
• All electrical medical devices must satisfy requirements of EN 60601-1:2006 (Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance) and EN 60601-1-2:2015 (Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests, or simply put – electromagnetic compatibility). All electrical medical devices for home use must comply with EN 60601-1-11:2010 (Medical Electrical Equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
• All devices with software must comply with EN 62304:2006 (Medical Device Software – Software life-cycle processes)

Product-specific harmonized standards are standards that define requirements for one specific product category, be that ECG or EEG equipment, anesthetic equipment or surgical gloves. For most of the medical devices, involving a notified body is obligatory.

The compliance with these product-specific standards provides evidence of the effectiveness of the medical device. If there is no such standard, the effectiveness must be proven through clinical investigation or literature-based clinical evaluation (comparison with equivalent medical devices described in peer-reviewed scientific journals; the approach that is very popular today but quite limited with new regulations).

For most of the medical devices, involving a notified body is obligatory. A notified body is an organization designated by the European Commission to verify compliance with respective directives/regulations. The list of notified bodies is kept in NANDO database (http://ec.europa.eu/growth/tools-databases/nando/).

A company wishing to obtain a CE mark should identify applicable harmonized standards and obtain test reports for them if applicable (ISO 10993 family of standards, electrical standards).

The company must also prepare documentation describing its quality management system in compliance with EN ISO 13485:2016. The FDA approval is similar to the EU approach, in the sense that the company should satisfy standards and implement a quality management system.

The final, but the most sensitive step is the compilation of the technical file according to the applicable directive and guideline NB-MED/2.5.1/Rec5. The technical file is then submitted to the notified body, which examines it but also examines the operation of the company on-site. If everything is in order, the notified body issues the EC certificate, permitting the company to put the CE mark on the product. (If there are any irregularities, the notified body gives nonconformities which the company should eliminate within 3-6 months.)

U.S.A. (FDA Approval)

The FDA approval is similar to the EU approach, in the sense that the company should satisfy standards and implement a quality management system. While standards are essentially the same, the quality management system is described in the FDA title 21 CFR Part 820 and is slightly wider than EN ISO 13485:2016.

Another difference is in the possibility (much embraced) to make the registration easier by claiming essential equivalence with the already FDA-approved devices (so-called predicate devices) in a process known as 510(k) application.

How Can This Help You?

If you are new in the medical device business and need someone to do the R&D process for you, talk to professionals with experience in medical device registration (like HTEC Group). They can make things much easier by providing you with the regulatory requirements from the beginning. In this way, you will avoid receiving a finished product which you can not register (at least not without further adjustments that could have been done a long time ago).