Source: http://www.lne-gmed.com/en/issues/revision-medical-devices-directives.asp
Timestamp: 2018-04-20 10:14:56
Document Index: 719562526

Matched Legal Cases: ['Art. 42', 'Art. 44', 'art 78', 'Art. 40', 'Art. 42', 'art 76']

Latest update : 04.10.2012
Home | Regulatory information | Revisions to the Medical Devices Directives
The European Commission states that the revisions may be adopted in 2014 and implemented between 2015 and 2019. 1
The European Commission gives three overall objectives to the revisions, which can be seen throughout the revision2. The first objective is to ensure that human health and safety is protected at a high level. To reach this objective, the Commission included, among other things, a chapter on the requirements of clinical studies, increased post-market surveillance and vigilance activities for economic actors and the competent authorities, and a chapter on the traceability requirement for all devices. The second objective that the Commission had is to ensure that the internal market continues to function smoothly. The Commission states that this objective is reached by “…[putting] in place a regulatory framework that is applied with consistency across the EU….”3 A consistent regulatory framework would include, for instance, the clauses that close the legal disparities in the provisions of each member-state and the handling of borderline products and classification issues. Also, Annex XV of the proposal for a regulation for medical devices lists products that are included in the expanded scope of the definition of “medical device,” providing further clarification. The third objective is to provide a regulatory framework that is not only consistent, but also supports innovation and competition in the European medical device industry. The Commission examined the many different suggestions to change the current system, and decided that a stronger version of the current third-party assessment system is the most efficient system, keeping innovation and competitiveness strong.
Chapter VII - Strengthening of the provisions governing market surveillance and vigilance.
Arts. 1 and 2 - Modification of the scope (including now some implantable or invasive products (see annex XV) even if they are not used for a medical purpose, and certain products manufactured utilising non-viable human tissues or cells);
Art. 42 - Strengthening of the provisions of unannounced factory inspections and sample checks;
Art. 44 – For some Class III medical devices, intervention, prior to the issuing of the certificate and in addition to the assessment procedure by the Notified Body, of a Medical Device Coordination Group (MDCG – see art 78) in charge of the review of the summary of the preliminary conformity assessment. The MDCG may request for any additional information, samples or an on-site visit to the manufacturer's premises;
Arts. 1 and 2 - Modification of the scope (including now some high-risk devices manufactured and used within a single health institution, tests providing information about the predisposition to a medical condition or a disease, dedicated medical software);
Art. 40 - Strengthening of the provisions of unannounced factory inspections and sample checks;
Art. 42 – For some Class D IVDD, intervention, prior to the issuing of the certificate and in addition to the assessment procedure by the Notified Body, of a Medical Device Coordination Group (MDCG – see art 76) in charge of the review of the summary of the preliminary conformity assessment. The MDCG may request for any additional information, samples or an on-site visit to the manufacturer's premises;
1 - http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm
2 - Commission Staff Working Document: Impact Assessment on the Revision of the Regulatory Framework for Medical Devices. Part I. SWD(2012) 273 final. Pg. 22-23.
3 - Id. at 23.