Harmonization of standards under the regulations for medical devices moves forward slowly

European Commission publishes draft standardization request

The European Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) have specific roles for harmonized standards in demonstrating conformity. Article 8 in each regulation indicates that harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonized standards are presumed to be in conformity with the requirements of the regulation covered by those standards. Additionally, the presumption of conformity applies to system or process requirements such those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations or clinical evaluation.

In order for a standard to be harmonized under the regulations, a standardization request has to be agreed between the European Commission and the European Standards organizations – CEN and CENELEC. The draft of this standardization request has now been published by the European Commission.  One month was given for comments and this comment period ended on 27 July 2019.

Annexes to the draft standardization request lists the standards to be revised and the deadlines for their adoption. The deadline for adoption of most of the listed standards is 27 May 2024, but there is a small number of standards that have a higher priority. Those with a deadline of 26 May 2020 are generally horizontal standards that apply to a wide range of manufacturers, including EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes and EN ISO 14971- Medical devices - Application of risk management to medical devices. The processes of revising EN ISO 14971 and amending EN ISO 13485 are underway.

Standards to support the MDR also with a deadline for adoption of 26 May 2020 are:

• EN ISO 14155 - Clinical investigation of medical devices for human subjects - Good clinical practice;
• EN ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements;
• EN 15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.

The IVDR also has a small number of standards with priority deadlines. These are:

• EN ISO 18113 Parts 1-5- In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) - with a deadline of 30 September 2021;
• ISO 20916 - In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice - with a deadline of 26 May 2022.

For the MDR, in addition, there are 63 new or revised standards identified with the longer deadline for adoption of 27 May 2024. These include standards for:

• Validation and routine control of sterilization and aseptic processing;
• Packaging for sterile devices;
• Biological evaluation;
• Devices using tissues of animal origin;
• Medical electrical equipment;
• Device software;
• Usability engineering.

For the IVDR, the list identifies 43 standards with the 27 May 2024 deadline for adoption. Several of these standards are also included in the list for the MDR, including those for sterilization and aseptic processing; device software; and, usability engineering. The listed IVD-specific standards include:

• Devices for self-testing;
• Performance evaluation;
• Elimination or reduction of risk of infection;
• Sampling procedures for acceptance testing;
• Use of external quality assessment schemes;
• Measurement of quantities in samples of biological origin;
• Blood-glucose monitoring systems for self-testing;
• Establishing metrological traceability;
• Evaluating stability of reagents.

Although the draft standardization request has the majority of deadlines in 2024, the standards bodies can publish the new or revised standards earlier than these deadlines. Many standards committees are already working on amending or revising the standards in their areas of responsibility.

If you use any of these standards, it is important to track progress with any amendments or revisions. There are resources available to help in BSI’s Compliance Navigator.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development