Medical Devices Services

• all non-invasive devices with some exceptions for surgical instruments and for invasive devices related to body orifices – lower risk

• invasive devices related to body orifices and invasive surgical nature, and devices based on substances

• invasive surgical devices and devices based on substances

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. applied as of May 2021:

• Reprocessing validation of single-use MD/reusable MD
• Risk Assessment
• Classification rules
• Usability and Labeling instructions for all MD
• Packaging Validation (not new but now more controlled by NO)
• Stability
• Material Characterization (e.g. E&L and Assays)
• New requirements for the post-market surveillance
• Shipping Validation

ISO 13485:2016 – Quality Controls includes new requirements and a definition of sterile barrier systems referring to ISO 11607. New requirements for packaging in this standard include preserving products through protecting “the product from alteration, contamination, or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by designing and constructing suitable packaging and shipping containers.” There are also requirements for preventing contamination of sterile devices with particulate matter during assembly and packaging.

ISO 14971:2007 – Risk assessment specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

ISO 10993-1:2018 – Biological evaluation of medical devices, Part 1:Evaluation and testing within a risk management process.

The document specifies:

• the general principles governing the biological evaluation of medical devices within a risk management process;
• the general categorization of medical devices based on the nature and duration of their contact with the body;
• the evaluation of existing relevant data from all sources;
• the identification of gaps in the available data set on the basis of a risk analysis;
• the identification of additional data sets necessary to analyse the biological safety of the medical device;
• the assessment of the biological safety of the medical device.

ISO 10993-18:2020 – Biological evaluation of medical devices, Part 18: Chemical characterization of medical device materials within a risk management process.

• The document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization

ISO 14155:2011 – Clinical studies addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

MEDDEV 2.7/1 – Clinical evaluations promotes a common approach to clinical evaluation for medical devices regulated by directives 90/385/EEC and 93/42/EEC. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.

EMA GUIDELINE DDCs (2019). The medicinal product dossier should include full evaluation of the impact of the device on the Quality Target Product Profile (QTTP), Critical Quality Attributes (CQA) and overall control strategy of the medicinal product.

Specific ISOs depending on the nature of the device