MedDev and NB-MED Recommendations

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1 Titel of 2.1 Scope, field of application, explanation of terms Guidelines relating to the application of AIMD and MDD: Definition of medical devices, accessory and manufacturer Guidelines relating to the application of AIMD and MDD: Field of application of AIMD Guidelines relating to the application of AIMD and MDD: Demarcation with Directive 65/65/EEC relating medicinal products; Procedure for consultation between Notified Bodies (MDD) and Competent Authorities for medicinal products Guidelines relating to the application of AIMD and MDD: Demarcation with Directive 89/336/EEC (EMC) and 89/686/EEC (PPE) /... X 2.1/1 (3/94) X 2.1/2 (5/93) X 2.1/3 (14/93) X 2.1/4 (13/93) Working Working Working / 04/ /55/ / Medical devices with a measuring function X 2.1/5 1) 06/98.../39/99 Representative sample X 2.1/Rec1 4 2) /123/99 Explanation of Terms X 2.1/Rec2 4 2) /123/99 Accessories and other parts for Active Implantable Medical devices X 2.1/Rec3 3 2) /123/99 Placing on the market of fully refurbished medical devices X 2.1/Rec5 3 2) /123/ Essential requirements EMC requirements X 2.2/Rec1 3 2) /123/99 Treatment of computer used to program implantable pulse generators X 2.2/Rec2 4 2) /123/99 Use-by for Medical devices X 2.2/Rec3 4 2) /123/ Reference to standards Publication of titles and references of European harmonized X 2.3/1 4 05/97.../35/98 standards under AIMD and MDD Standardization man to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices 2.4 Classification (4/94) X 1/97 Draft 01/97.../36/98 1) based on earlier NB-MED Recommendation 2.1/Rec4; rationale & history: see attached Annex I 2) rationale & history: see relevant NB-MED Recommendation VdTÜV - Technical Secretariat NB-MED PO Box , D Essen G. Hinrich Schaub (- 178), Jörg Höppner (- 138) Kurfürstenstraße 56, D Essen Phone:++49/201/8987-0; Fax: ++49/201/ or vdtuev.hoeppner@t-online.de

2 Titel of /... Guidelines to the classification of Medical devices X 2.4/1 (10/93) (Guidelines to the classification of Medical devices) X 2.4/1 (10/93) 2.5 Conformity assessment procedures Guidelines for regulatory auditing of quality systems of medical device manufacturer Guidelines for regulatory auditing of quality systems of medical device manufacturer Guidelines on assessment of medical devices incorporating materials of animal origin with respect to viruses and transmissible agents Guidelines for conformity assessment of breast implants according to MDD General rules / 5 th draft 5 03/96 (working ; only for information) 09/99 (.../13/00) X 2.5/2 final draft /34/98 (1/94) X final draft /57/98 X 2.5/5 Working 1 05/98.../101/98 (NBRG comments:.../4/00) X 2.5/6 Final draft 1 07/98.../125/98 Content of mandatory certificates X 2.5.1/Rec4 3 2) /123/99 Renewal of EC Design-Examination and Type-Examination Certificates X 2.5.1/Rec6 3 2) /123/ Quality assurance Subcontracting - QS related X 2.5.2/Rec1 4 2) /123/99 Reporting of design changes and changes of the quality system X 2.5.2/Rec2 3 2) /123/99 Translation procedure X 2.5.2/Rec3 4 2) /123/ Type examination Verification of manufactured products Homogeneous batches X 2.5.4/Rec1 4 2) /123/ Conformity assessment for particular product groups Combination of CE-marked and non-ce-marked medical devices and non-medical devices 2.6 CE marking 2.7 Clinical investigations, clinical evaluation X 2.5.5/Rec2 3 2) /128/99 02/00 2/6

3 Titel of /... / Guidance on clinicals X 2.7/Rec1 3 2) /123/99 Evaluation of clinical data X 2.7/Rec3 3 2) /123/ Devices intended for special purposes 2.9 Systems and procedure packs 2.10 Notified Bodies List of Notified Bodies under AIMD and MDD X 2.10/ /39/98 (10/94) X 2.10/2 draft working Designation and monitoring of Notified Bodies within the framework of EC Directives on Medicalo Devices 2.11 Registration procedure 2.12 Market surveillance; vigilance Guidelines on a medical devices vigilance system X 2.12/1 (3/93) 03/99.../71/ /98.../56/98 Post-Marketing Surveillance (PMS) post market/production X 2.12/Rec1 3 2) /123/ Transitional provisions.../123/99 CE Marking of pre-mdd Devices X 2.13/Rec1 3 2) Implementation Implementation of AIMD Directive into national law X 2.14/1 (8/94) 07/97.../37/98 Implementation of MD Directive into national law X 2.14/2 (9/94) 2.15 Other Committees/working parties relevant for medical devices X 2.15/1 (2/94) 03/97.../38/ /97.../33/98 Global Harmonisation Task Force X 6/94 p.1 6/94 p Voluntary certification at an intermediate of manufacture X 2.15/Rec1 3 2) /177/99 02/00 3/6

4 planned and/or others: Titel of /... / 2.1 Scope, field of application, explanation of terms 2.2 Essential requirements Design dossier X 2.2/Rec5 hold will be replaced by the on Technical ation 2.3 Reference to standards 2.4 Classification 2.5 Conformity assessment procedures General rules Declaration of conformity X 2.5.1/Rec2 Postpone now Consensus statement Technical ation X 2.5.1/Rec Febr Quality assurance Type examination Verification of manufactured products Conformity assessment for particular product groups Conformity assessment procedures of breast implants X 2.5.5/Rec1 deleted superseded by 2.5/6; rationale & history: see Annex II Febr CE marking 2.7 Clinical investigations, clinical evaluation Clinical evidence X 2.7/Rec already covered by Guidance on clinicals and Evaluation of clinical data 2.8 Devices intended for special purposes 2.9 Systems and procedure packs 2.10 Notified Bodies 2.11 Registration procedure 2.12 Market surveillance; vigilance 2.13 Transitional provisions 2.14 Implementation 2.15 Other 02/00 4/6 vdtuev- dn:...\hoeppner\mp\nb\rec_vdt2\meddev_nb_01

5 on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Overwiev List of rationale & history-sheets on earlier which superseded by -s. a) Medical devices with a measuring function NB-MED Recommendation NB-MED/2.1/Rec4 Medical devices with a measuring function ( 3, Rev.-Nr. 6, Rev ) was superseded by - 2.1/5 Medical devices with a measuring function (June 98, distributed to NB-MED as NBM/39/99). Rationale and history sheet: Annex I Rev. 5: Medical Devices Expert Group Meeting, Brussels, February 9/10, 1998: The 4 Medical devices with a measuring function was presented to the Medical Devices Experts Group but was not fully ; the following comments were made (see NB-MED/2.1/R4): page 1, 1st paragraph: delete meteorological, insert metrological French comment: would like to add positive examples for anatomical parameter page 2, last paragraph: insert: device for measuring volume or pressure or flow of liquid... German comment: would like to send a proposal for modifying the expression... without graduation or scale (see page 3) After considering the French and German comments including a earlier statement made by EMIG the will become a MEDDEV. Meeting of NBR Group, Brussels, April 20 & 21, 1998: The NBRG reworked the (above mentioned editorials) and made the clarification under c): c) the intended purpose implies accuracy, claimed explicitly or implicitly, where a non-compliance with the implied accuracy could result in an significant adverse effect the patient s health and safety. Also the note 2 was modified by deleting the example: Note 1: The expression claimed implicitly covers cases where the user, on the basis of the designation of the device or of its accompanying s, or on the basis of the common use is entitled to expect accuracy (examples: a device designated with the use of the suffix -meter or a device where the accuracy of the measurement has an impact on the diagnosis or therapy of the patient). On occasion of the next NB-MED meeting on June NB-MED will be informed about this changes; further consideration will be done by the Medical Devices Experts Group Confirmed at 3 New revision no: 5 Rev. 6: Notified Body Meeting, Brussels, June 09 & 10, 1998: The was tabled on the Notified Body Meeting on 09./ One modification was made in the paragraph for Examples for class I devices with a measuring function: - device for measuring volume or pressure or flow of liquid or gases delivered to or removed from the human body (included any container with a graduation scale or with a single point graduation, where criteria c) is met) Confirmed at 3 New revision no: 6 Rev. 7: Notified Body Meeting, Brussels, November 3 & 4, 1998: : The new was tabled to the NB-MED as NBM/148/98. Only slight editorial changes were made due to discussions within the Medical Devices Experts Group. NB-MED agreed to supersede the old NB-MED Recommendation NB-MED/2.1/Rec 4 by this 2.1/5 (issued June 98). Confirmed at 5 (NB-MED took note of this new ) New revision no: 7 02/00 5/6

6 on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Overwiev List of rationale & history-sheets on earlier which superseded by -s. b) Conformity assessment procedures of breast implants NB-MED Recommendation NB-MED/2.5.5/Rec1 Conformity assessment procedures of breast implants ( 3, Rev.-Nr. 4, Rev ) was superseded by - 2.5/6 Guidelines for conformity assessment of breast implants according to MDD ; (July 98, distributed to NB-MED as NBM/125/98). Rationale and history sheet: Annex II Rev. 4: Notified Body Meeting, Brussels, June. 24 & : The draft Recommendation for conformity assessment procedures of -breast implants was revised on and subject to discussion by the Medical Device Experts Group at their meeting on 25 February This was prepared by NB-MED Task Force Conformity assessment for breast implants (Convenor: Dr. Müller- Lierheim/MDC; Members: Mr Binard/G-MED, Mr Chitarrini/,Laboratoires Sebbin, Mr Dawids/DMDC, Dr. de Jong/MENTOR Medical Systems, Dr. Eisenmann-Klein/Caritas Krankenhaus St. Josef, Mr Gügel/TÜV Product Service, Mr Hüser/Polytech Silimed Europe, Ms Jeanty/LPI - Laboratoire Perouse Implant, Dr. Laufer/Collagen/LipoMatrix, Ms Meyer/SSF, Mr Rentschler/MDC, Mr Thalen/IAPM, Mr Tinkler/MDA Medical Device Agency, Dr. Tschöpe/BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte, Ms White/McGhan, Mr Wild/SHG-D). With some minor changes requested by the Medical Device Experts Group the was tabled on the Notified Body Meeting on 24./ The was approved by the NB-MED plenary. Meeting of NBR Group, Brussels, June 26 & : The NBRG has brought the into the format of a NB-MED recommendation and issued it among their 3 - recommendations. It was decided to give a proposal to the Medical Device Expert Group concerning a concluding discussion of the use of shall / should and the consideration of Liquid Implants. Confirmed at 3. New revision no: 4 Meeting of NBR Group, Essen, September 29 & : It was decided to fit the in the new recommendations nomenclature system (chapter Conformity assessment procedures; Conformity assessment for particular product groups). Therefore the recommendation gets the number NB-MED/2.5.1/R1. Rev. 5: Notified Body Meeting, Brussels, November 2 & : It was mentioned that the 3 Recommendation on breats implants needs some further development; since the adoption in 1997 the Commission has done a lot of work to this subject which is not be reflected by the present Recommendation. The French Competent Authority is waiting for a strongest Commission s to withdraw banning of such devices. Meeting of NBR Group, Brussels, November 3, 1999: It was propsed by Mr. V. and subsequently agreed at the NBRG meeting that NB-MED Recommendation No /Rec1 on Breast Implants should be withdrawn from the list of because a revised 2.5/6 is in preparation, the context of which more accurately identifies the requirements relating to this product. The revised will be included when agreed and published; in the meanwhile the former and existing 2.5/6 (issued as final draft 07/98) is still valid and supersedes this Recommendation. The Technical Secretariat was asked to rework the rationale & history of this Recommendation and the list of and to withdraw this Recommendation. Meeting of NBR Group, Cologne, February 3, 2000: NBRG agreed with tabled and the described procedure to handle this Recommendation. Confirmed at delete. New revision no: 5 02/00 6/6

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