Medical devices within the EU are currently regulated by three Directives: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)Read More
The EU has proposed a new regulation on cybersecurity. While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.” The new tasks include: Facilitating the establishment and take-up of European...Read More
The EU MDR of April, 5, 2017 is at the link below. Clause (19) states: “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a...Read More
National Law Review discusses a case before the EU Court of Justice to decide if medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device. The manufacturer prefers it to be considered a medical device to avoid more onerous requirements if it is not treated that way.Read More
The European Union has published a Directive concerning measures for a high common level of security of network and information systems across the Union. The directive does not impose any new requirements on manufacturers that are not operators of essential services or digital services. Instead, it relies on existing rules on product liability. EU Network...Read More
This agreement includes a number of clarifications to the EU Medical Device Regulations. The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15. The text of the draft MDR is at the link provided. The text...Read More
A new International Medical Device Regulators Forum (IMDRF) document was finalized. It is Software as a Medical Device (SaMD): Application of Quality Management System. The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD. View the document at this link: imdrf-tech-151002-samd-qmsRead More
The EU Commission published “Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.” This clarifies and strengthens the criteria for certifying (and auditing) notified bodies, and the criteria that the notified bodies have to use in assessing companies and products. The main changes...Read More
A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to...Read More
The European Commission has issued a final guidance on standalone software entitled: “GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES.” Updated in 2015.Read More
The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software. In some instances it is more specific than FDA requirements. The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June...Read More
This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”Read More
The EU standardization organizations, CEN and CENELEC, have formed a joint working group on standards for software and medical devices (SAMD). The first meeting will be December 8th. Notice is at the link provided. With the harmonization of IEC 62304 (including for IVD devices), potential modifications to the scope of 60601, and the recent Medical...Read More
The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been...Read More
The EU parliament released a final revision of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). It includes a number of additions related to software. These additions and clarifications stress that standalone software can be a medical device but not all software used in healthcare is a medical device. It also...Read More
The EU is now close to release of a revision of the Medical Device Directive (MDD). The full text with change marks is at the link provided. The MDD has expanded clause 12.1 into an (a) and (b) sub-clause with the latter specifically addressing software and the former being the original 12.1. The text of...Read More
The EU issued proposed new text for the Medical Device Directive (MDD). The document with highlighted revisions, additions, and deletions is at the link provided. The proposed changes include several additions to more explicity address software. These include adding: the word “software” into the definition of a medical device in section 2(a) Annex I 12.1b...Read More
A presentation of a proposal for EU software regulation at the ISPRA meeting on Medical Device Software May 13, 2003, is at the link provided. Some of the suggestions are based on FDA guidance documents. ISPRA Meeting on SW This presentation was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices, which is an affiliate of SoftwareCPR....Read More
A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.Read More
Need Your Input!
We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course? What are the least favored (not workable) months?