New and Revised MEDDEVs for the European Union
The European Medical Device Expert Group (MDEG) convened on Tuesday January 10, 2012 in Brussels. As an outcome, three MEDDEV documents have been revised, two new MEDDEVs added, and one Qualification and Classification document introduced. Only some of these documents have been officially posted to the EU Commission website as of today. The following highlights some salient points of the new and revised MEDDEVs:
MEDDEV 2.12.1, Rev. 7 – Guidelines on a Medical Devices Vigilance System
Most notably, the seventh revision to MEDDEV 2.12.1 includes Report Forms for Periodic Summary Reporting (PSR) and Trend Reporting Annexes 6 and 7, respectively. The FSCA Reports templates will be available in XML format (to join the Incident Report form) and it is expected this will be followed by PSR and Trend Reporting forms as well. An emphasis is placed on use-errors when the criteria for an incident is considered, additional FSCA examples added to Annex 1, and Annex 11 on how to involve users in vigilance.
To recognize the status of Turkey as a candidate for EU accession, the document adds Turkey alongside the EEA and Switzerland.
The document also contains a number of revisions, such as an expansion on the concept of IVDs to “devices that do not act directly on the individual” and In Vitro Fertilization and Assisted Reproductive Technology (IVF/ART). The use of IVF/ART coincides with a new guidance on this topic.
Other significant revision includes the mandatory use of EUDAMED among Competent Authorities to exchange NCARs to align with the Commission Decision.
MEDDEV 2.12.2, Rev. 2 – Post Market Clinical Follow-up Studies
Post market clinical follow-up (PMCF) is the subject of MEDDEV 2.12.2 which has been revised to address the amendments made by Directive 2007/47/EC. This revision is considerably more detailed and addresses post market surveillance as a necessary part of monitoring additional risks that may not become apparent until after long-term use of a device. The revised document provides more detailed guidance as to when a PMCF is indicated, its general principles, use of study data, and the role of PMCF in the ongoing Conformity Assessment Procedure.
MEDDEV 2.14.1, Rev. 2 – IVD Medical Device Borderline and Classification Issues
The second revision of MEDDEV 2.14.1 on IVD classification has been significantly expanded (from 8 to 21 pages) into two parts, the qualification and the classification of IVD, to more closely resemble the guidance on classification of medical devices (MEDDEV 2.4.1, Rev. 9). There are numerous qualifications on the following topics: specimen receptacles, products to obtain specimens, products for general laboratory use, IVD kits, microbiological culture media, stains, and devices with an invasive body contact with no IVD purpose. Of particular note is the discussion on general laboratory use products which cannot be considered IVDs merely because the indication for use includes the phrase “for in vitro diagnostic use.” The latter part on classification discusses some IVDs in Annex II, List A and List B of 98/79/EC.
MEDDEV 2.5.10, Rev. 1 - Guideline for Authorized Representatives
The new MEDDEV, Guideline for Authorized Representatives, was finalized. This document aims to provide clarification on the role and responsibilities of Authorized Representatives (AR). It underscores the importance of the AR’s competency. It also defines Member States' expectations as to the role of the AR. The guideline highlights the importance of establishing a written contract between manufacturer and AR. The contract should clearly delineate tasks that the manufacturer delegates to its AR such as the AR Agreements which exist between the Authorized Representative and manufacturers.
MEDDEV 2.5.10 stresses that the manufacturer must keep its AR informed in all matters that may be connected to a device placed on the market in the EU. Likewise, the AR must keep the manufacturer informed and updated in all matters regarding the device. Furthermore, the presumption is that a Member State will receive all the information it requests when it addresses the AR. For that reason, the manufacturer is obliged to make documentation and information readily available to the AR.
MEDDEV 2.2.4 Guidelines for Conformity Assessment IVF/ART products
MEDDEV 2.2.4 underscores the importance of post market clinical follow-up (PMCF), traceability and vigilance specifically to IVF/ART devices within Directive 93/42/EEC. Due to the enduring impact of IVF/ART products, incidents may be revealed well after the device has been used. This new MEDDEV document delineates hazards and risks inherent specifically related to IVF/ART devices.
Guidelines on Qualification and Classification of Stand Alone Software
A document outlining classification rules on standalone software has been developed. Standalone software may be classified as an active medical device under 93/42/EEC or as IVD medical device under 98/79/EC. This document provides decision diagrams and criteria that will facilitate classification of these types of devices.
Other current activities in the EU include the Agenda for meetings in 2012, which the EU Commission has recently posted. Note the EU’s commitment to this expected draft medical device legislation (regulation) in 2012, as there are meetings scheduled for February 6th and 13th, titled Special MDEG meeting “revision MD legislation.”
Lastly, standard EN ISO 14155:2011 will soon be included in OJEC as an European Norm harmonized standard.