Activities of Marian HARKIN related to 2012/0266(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Amendments (21)
Amendment 18 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) This Regulation includes requirements regarding the design, safety and performance characteristics of medical devices intended to prevent occupational injuries as laid down in Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU1. It must be recognised that these requirements would only apply in health settings specifically recognised in the Framework Agreement between HOSPEEM and EPSU and this Regulation should enable separate discussions to take place in other settings such as dental clinics which were not embraced by that Framework Agreement. ________________ 1 OJ L 134, 1.6.2010, p. 66.
Amendment 27 #
Proposal for a regulation
Recital 53
Recital 53
(53) Healthcare professionals and patients should be empowered to report suspected serious incidents, which affect the safety of patients, care givers, healthcare professionals or others, at national level using harmonised formats. The national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 29 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 45
Article 2 – paragraph 1 – subparagraph 1 – point 45
(45) ‘corrective action’ means action taken to eliminate the cause of a potential or real non-conformity or other undesirable situationnon-conformities in order to prevent recurrence;
Amendment 31 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 46
Article 2 – paragraph 1 – subparagraph 1 – point 46
(46) ‘field safety corrective action’ means corrective action taken by the manufacturer for technical or medical reasons to prevent orto reduce thea risk of adeath or serious incident in relation to a device made available on the marketdeterioration in the state of health associated with the use of a medical device;
Amendment 34 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 47
Article 2 – paragraph 1 – subparagraph 1 – point 47
(47) ‘field safety notice’ means thea communication sent by theout by a manufacturer to users or customor its representative to the device users in relation to a fField sSafety cCorrective aAction;
Amendment 35 #
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 36 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 52 #
Proposal for a regulation
Article 44 – paragraph 6 a (new)
Article 44 – paragraph 6 a (new)
6a. Throughout this process, the views of all relevant stakeholders including patients, caregivers or healthcare professionals' organisations, shall be taken into account.
Amendment 54 #
Proposal for a regulation
Article 94 – paragraph 4
Article 94 – paragraph 4
4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application provided that the relevant delegated and implementing acts have entered into force.
Amendment 60 #
Proposal for a regulation
Annex 1 – part II – point 11 – point 11.2 a (new)
Annex 1 – part II – point 11 – point 11.2 a (new)
11.2a. Devices which can transfer potentially fatal blood-borne infections to healthcare staff, patients or other persons, by unintended cuts and pricks such as needle stick injuries, shall incorporate appropriate safety-engineered protection mechanisms in accordance with Directive 2010/32/EU. However the specificities relating to the dental profession must be respected.
Amendment 248 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 5 – indent 2 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 5 – indent 2 – paragraph 2
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be considered an implantable device; 'implantable device' means any device, including those that are partially or wholly absorbed, which is intended
Amendment 407 #
Proposal for a regulation
Article 16 – title
Article 16 – title
Implant cardnformation about implantable devices
Amendment 414 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall provide together with the device an implant cardinformation which shall be made available to the particulsubmitted to the healthcare patient who has been implanted with the devicerofessional implanting the device who will be responsible for: - submitting this information to the patient; and - recording this information in the patient's medical records.
Amendment 419 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 – introductory part
Article 16 – paragraph 2 – subparagraph 1 – introductory part
This cardinformation shall contain the following:
Amendment 443 #
Proposal for a regulation
Article 24 – paragraph 7 – point a
Article 24 – paragraph 7 – point a
(a) determining the devices, categories or groups of devices whose identification shall be based on the UDI system as set out in paragraphs 1 to 6, and the timelines for implementing this. Following a risk-based approach, implementation of the UDI system shall be gradual, starting withrestricted to devices falling in the highest risk class;
Amendment 444 #
Proposal for a regulation
Article 24 – paragraph 7 – point b
Article 24 – paragraph 7 – point b
(b) specifying the data to be included in the production identifier which, following a risk based approach, may vary depending on the risk class of the device;
Amendment 537 #
Proposal for a regulation
Article 41 – paragraph 3 – subparagraph 2
Article 41 – paragraph 3 – subparagraph 2
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Before adopting implementing acts, the Commission shall consult with relevant stakeholders and take into account their suggestions.
Amendment 539 #
Proposal for a regulation
Article 41 – paragraph 4 – point b
Article 41 – paragraph 4 – point b
(b) amending or supplementing the classification criteria set out in Annex VII. Before adopting delegated acts, the Commission shall consult with relevant stakeholders and take into account their suggestions.
Amendment 706 #
Proposal for a regulation
Article 78 – paragraph 6
Article 78 – paragraph 6
6. Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to MDCG meetings in the capacity of observers. The MDCG may invite, on a case-by- case basis, other experts and other third parties to attend meetings or provide written contributions.
Amendment 782 #
Proposal for a regulation
Annex 1 – part II – point 11 – point 11.7
Annex 1 – part II – point 11 – point 11.7
11.7. Devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and the substances with which the device has been exposed to and/or of any waste substances by the user, patient or other person and, where possible and appropriate, replace with the use of devices and methods with improved safety features and characteristics to reduce as far as possible the exposure of patients, users and other persons to potentially harmful substances, such as chemical or nuclear material.
Amendment 852 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot beintended to be intentionally released into the patient's or user's body when the device is used within its intended purposehuman body are classified as class III.