Big changes in the world of EU harmonized standards

We note that there is considerable change in the world of harmonized standards. A snapshot document published by the European Committee for Standardization (CEN) presents the latest on forthcoming standards that will be harmonized to the three EU medical devices directives. Notably, the 2012 version of EN ISO 15223-1 will replace EN 980 as the recognized standard for symbols to be used in medical device labeling. Moreover, two of the most important standards for manufacturers in the European Community, ISO 13485 and ISO 14971, will see updated versions published.

When EN 980:2008 is officially withdrawn on 31 January, 2013, the European Norm standard will be superseded by EN ISO 15223-1:2012. While many of the symbols in EN 980 were largely in ISO 15223-1:2007/Amd 1:2008, both standards are now one international standard and the EN 980 EC REP symbol designating Authorized Representative has been added to EN ISO 15223-1. Additional symbols (not previously included in EN 980) are introduced via EN ISO 15223-1. These include humidity and atmospheric pressure limitations, sampling site, fluid path, non-pyrogenic, drops per mL, liquid filter, patient number, one-way valve, and protect from heat and radioactive sources.

The symbols listed above will need to be explained by the manufacturer in accompanying Instructions for Use or packaging. Moreover, EN ISO 15223-1 adds the “wine goblet” or “fragile, handle with care” symbol (which was not included in EN 980), but this symbol will not require additional explanation.

Other significant changes include revisions of ISO 13485 and ISO 14971. While ISO 13485:2012 will not see any changes in the Normative Text and the requirements will remain unchanged, revisions have been made to the informative Annexes. These annexes now further clarify how the standard can be used to support the Essential Requirements of the medical devices directives. Emergo Group understands that ISO 14971, which is expected to be superseded this summer by an updated version (ISO 14971:2012), has only undergone slight revisions. Although the application of harmonized standards is not mandatory in the EU it helps demonstrate compliance with required elements (Essential Requirements, Annex I).

There may still be some time until these standards are officially harmonized by means of publication in the Official Journal of the European Union. Also, it has been mentioned that the draft medical device legislation will be publically available in September 2012.

February 22, 2012

EU Publishes EN ISO 13485:2012

The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012. This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. The revised standard will be available in the upcoming weeks.

EN ISO 13485 provides a framework to enable a manufacturer to meet some of the quality system requirements for an EC Declaration of Conformity (Annex 2 and Annex 5 of Directive 90/385/EEC AIMD; Annex II, V and VI of Directive 93/42/EEC MDD; or Annex III, IV and VII of Directive 98/79/EC IVDD). As the EU harmonized standard for medical device quality management systems, it is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation, based on a sound regulatory interpretation for implementation in their quality management systems.

During 2011, The European Commission raised an objection to the harmonization status, and the implied Presumption of Conformity of a number of European Standards including EN ISO 13485. Additionally, Sweden raised a formal objection to the European Commission in February 2011 on the link between adhering to the standard and compliance to the Directives.

To restore confidence and bring back the presumption of compliance indicated by the harmonized status of the standard, it was essential to revise the Annexes ZA, ZB and ZC and add further details on the link between standards, and the three Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. All signs are clear for the new EN ISO 13485:2012 to be harmonized, and will most likely happen by summer 2012.

Once EN ISO 13485:2012 is harmonized, there will be no need for existing BSI customers with ISO 13485 certificates (UKAS accreditation) to undergo an automatic update or re-issue of certification. This is because there is no changed in the normative text (requirements) of the standard.

After the date of harmonization, any new BSI ISO 13485 certificates (UKAS accreditation) issued will specify ISO 13485:2012, and any existing certificates being renewed or reissued to support changes after this date will be updated at the point of reissue to also refer to ISO 13485:2012. All BSI ISO 13485 certificates issued under SCC accreditation (including CMDCAS) will continue to reference ISO 13485:2003 as it is only the European version of the standard that is changing.

Medical Device Vigilance
and Guidance Revisions

MEDDEV 2.12-1 rev.7

The guidelines on a Medical Device Vigilance system (MEDDEV 2.12-1 rev.7 ) have been reviewed and updated to include the new Manufacturers Incident Report Form and the FSCA Form (listed as Annex 3 & 4) on the basis of experience.

In addition, templates for Manufacturers Trend Reporting and Manufacturers Periodic Summary Reporting (Annex 7 & 8) are being introduced, moving from reaction to prevention where possible. The reporting forms are based on GHTF templates. They will be made available in XML format, including instructions for use, in anticipation of the European database (EUDAMED) being ready for electronic input.

Details on reporting to Turkey have been added, and clarification has been provided for cases where a device does not directly come in contact with patients, such as in IVF/ART (In Vitro Fertilization). In addition a number of additional scenarios in reportable events have been added. Clarification on IVD reporting may be clarified in the next revision, scheduled for Spring 2012.

MEDDEV 2.12-2 rev.2

The guidance on Post Market Clinical Follow-Up (PMCF) studies (MEDDEV 2.12-2 rev.2) provides much improved guidance to manufacturers and Notified Bodies in replacing MEDDEV 2.12-2 Clinical Evaluation - Post Market Clinical Follow-Up dated May 2004 and implementing section 1.1.c of Annex X of the Medical Device Directive (MDD).

The new document follows the GHTF guidance and adds details on EU legislation. The guidance emphasizes the increased need for PMCF studies to be considered in drafting the risk-based PMS plans given the revised focus on clinical data introduced by 2007/47/EC revision of the MDD and AIMD directives. It clearly references the recently issued ISO 14155:2011 as basis for clinical studies and provides details on the evaluation of PMCF by Notified Bodies. More general guidance on PMCF and its relation to legislation and interaction and cooperation with registries will be provided in subsequent guidance that will be drafted. Attempts are ongoing to better embed PMCF and PMS planning into the future legislative framework in EU.

MEDDEV 2.5/10

A new guideline has been established for Authorized Representatives (MEDDEV 2.5/10), which also requires the prior approval of joint EU authorities (CAMD). The document discusses the role and designation by the manufacturer of the Authorized Representative. It details registration requirements and possible elements to be covered in the Authorized Representative Contract. If the manufacturer is not enabling the Authorized Representative to follow legal requirements, they can terminate the contract. A large section deals with the interactions between the Representative and the Competent Authorities. In addition it specifies the element the Notified Body should reflect on during conformity assessments.

MEDDEV 2.2/4 IVF ART

A new guideline on IVF ART (MEDDEV 2.2/4), also based on earlier CAMD documentation, was introduced. The guideline concerns media, substances, or mixture of substances used during IVF and ART procedures which fall under the MDD with the exception of objects such as receptacles, petri dishes, pipettes or syringes. It provides the basis for hazard and risk assessment, and focuses on the elements that need to be in place for CE Marking . It discusses elements such as toxic and carcinogenic additives, drug and human derivatives added, clinical studies, Notified Body essentials, sterilization and the appropriate use of clean rooms during production. Other sections detail classifications, traceability and vigilance reporting challenges.

MEDDEV 2.14/1 rev.2 and IVD’s

The guidance on Medical Device - Borderline and Classification issues on IVD (MEDDEV 2.14/1 rev.2) has been updated and revised to include more detail on some essential qualification criteria and classification issues.

Healthcare Software

A new guideline on the qualification and classification of stand-alone software used in healthcare (no number assigned yet) within the regulatory framework for medical devices was introduced after two years preparation.

The document includes criteria for qualification as medical device or as IVD Medical Device and deals with classification of software as active therapeutic medical device, software intended for diagnosis or therapy and software in conjunction with in vitro diagnostic devices. It provides examples of qualification and classification for software used in the healthcare environment such as Hospital Information Systems, Decision Support Software, Information Systems, Electronic Patient Records Systems (Clinical Information Systems /Patient Data Management Systems, Pre-hospital Electrocardiograph System, Radiological Information System, Picture Archive Communication System, Telemedicine Systems (such as telesurgery, video appointment software, and home care monitoring, wired or mobile), Web systems for monitoring of data. It also illustrates IVD software such as Laboratory Information Systems, Work Area Managers, Expert Systems, Interpretation of raw data and Home care monitoring, wired or mobile.

The last endorsed document provides guidelines for the CE marking of blood based IVD Medical Devices for vCJD based on detection of abnormal PrP. It follows the issuance late December 2011 of two new amending directives adding vCJD disease to IVD ANNEX II list A, and amending the Common technical Specifications: Commission Directive 2011/100/EU of 22 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices and Commission Decision 2011/869 of 22 December 2011 amending Decision 2002/364/EC on common technical specifications for IVD Medical Devices. Both changes become effective on July 1, 2012.

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