55.2017 eau] Official Journal of the European Union Lu (legilave acs) REGULATIONS REGULATION (EU) 2017|745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ‘of 5 April 2017 fon medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385]EEC and 93/42]EEC (Text with EEA relerance) ‘TIE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Artie 114 and Avricle 168(4() thereof, Having regard to the proposal from the European Commission, ‘Alier transmission ofthe draft legislative act to the atonal parliaments, Having regard to the opinion of the European Economic and Social Commitee ( After consulting the Committee ofthe Regions, ‘Acting in accordance with the ordinary legislative procedure (, Whereas: a) Q Council Directive 90)385)EEC () and Council Directive 93/42/EEC (1 constiute the Union regulatory framework for medical devices, other than in viro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation This Regulation aims to ensure the smooth functioning ofthe intemal market as regards medical devices, taking as a base a high level of protection of health for patents and users, and taking into accourt the small and ‘ediumsized enterprises that are active in this sector. At the same time, this Regulation sets high standards of ‘qualty and safety for medical devices in order to mest common safety concems as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaxy on the Functioning of the European Union (TFEUJ, thie Regulation hamonises the rules for the placing on the market and putting into service of medical devices and thei accessories on the Union market thus allowing them to benefit from the principle of free movement of goods {) Opinion of 14 February 2013 (0}€133, 9.52013, 9.52). (0 Bestion ofthe European Palsmentof 2 April 2013 fot et published in the Ofc oural and poston of the Counc a fist eding (of? March 2017 (at yet public in th cl our, (9 Coune Directive 90)383)EEC of 20 june 1980 on the approximation of the laws ofthe Member Sates elating to active implantable eddies (0) L189, 0.71990, p17, (Counc Diese $3/42/EEC O14 june 1993 concerning medial devices (0) 168, 127.1993, p 1),55.2017 Official Journal of the European Union Lures Arte 9 Common specifications 1. Without prejudice to Article 12) and 17(S) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sulficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes Il and Il, the clinical evaluation and post-marketclinial follow-up set out in Annex XIV or the requisements regarding clinical investigation set out in Annex XV. Those implementing acts shall be sddopted in accordance with the examination proceduce referred to in Article 1143) 2. Devices that are in conformity with the CS refered to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant pats of those CS. 3. Manufictzers shall comply with the CS refered to in paragraph 1 unless they can duly justify that they have ‘eloped solutions tht ensure a level of sey and performance thet i least equivalent thereto 4. _ Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products, Amide 10 General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation, 2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex | 3. Manufacturers shall conduct « clinical evaluation in accordance with the requirements se out in Article 61 and ‘Annex XIV, including a PMCF. 44. Manufacturers of devices other than custom-made devices shall draw up and kesp up to date technical documen- tation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed The technical documentation shall include the elements set out in ‘Annexes I and Il The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes Il and I. 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex Xill 6. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made of investigational devices, shall draw up an EU Geclaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Antle 20. 7. Manufacturers shall comply with the obligations relating to the UDI system eefered to in Article 27 and with the registration obligations referred to in Articles 29 and 31 8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Aricle 56, avaliable for the competent authorities for a period of at least 10 years after the lest device covered by the EU declaration of conformity has been placed on the market Inthe case of implantable devices, the period shall be a least 15 years after the last device has been placed on the market. Upon request by @ competent authority, the manufacturer shall, as indicated therein, provide tha technical documen- tation in its entirety ora summary thereot. ‘A manufactures witha registered place of business outside the Union shall, inorder allow its authorised representative to fulfil the asks meationed in Article 11(3}), ensure that the authored representative has the necessary documentation permanent availableLu Official Journal of the European Union 55.2017 9. Manufactures shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation, Changes in device design or characteristics and changes inthe harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely ‘manner, Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with thie Regulation in the most elfecve manner and in a manner that is proportionate to the risk class and the type of device. ‘The quality management system shall cover all parts and elements of 2 manufacturers enganisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required ro implement the principles and actions necessary to achieve compliance with the ‘provisions of this Regulation, ‘The quality management system shall address at least the following aspects: {a} a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications othe devices covered by the system: (©) entification of applicable general safety and performance requirements and exploration of options to adress those requirements; (© responsibil ofthe management (2) resource management inlading selection and contro of supplies and sb-conastors (0) risk management as ost nin Seton 5 of Annex (cin evahition in accordance with Article 6 and Annex XN; ncading PUCK: (@) product realisation, including planing desig, developmen, production and service provision; () verification of the UDI assignments made in accordance with Article 27(3) 0 all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29: (@)_setingup, implementation and msincenance of a post-market surveillance system, in accordance with Article 83 handling communication with competent authorities, notified bodies, ther economic operators, customers andlor other stakeholders; (&)_ processes for reporting of serious incidents and feld safety corrective actions in the context of vigilance: () management of corrective and preventive actions and verification of their effectiveness (in) processes for monioring and measurement of ourput, data analysis and product improvement 10, Manufacturers of devices shall implement and keep up to date the post-masket surveillance system in accordance with Artcle 83, 11. Manufactures shall ensure that the device is accompanied by the information set out in Section 23 of Annex {in an oficial Union languages) determined by the Member State in which the device is made avalable co the user or patient. The particulars on the label shall be indelible, easly legible and clearly comprehensible tothe intended user 01 patient 12, Manufacturers who consider or have ceason to believe that a device which they have placed on the market or put ino service is notin conformity with this Regulation shall immediatly take the necessary corzerive action to bring that device into conformity, to withdraw itor to real i, 25 appropriate, They shall inform the distributors ofthe device in ‘question and, where applicable, the authorised representative and importers accordingly ‘Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable the notified body that issued a cerifiate for the device in accordance with Article 56, in particular, ofthe non-compliance and of any corrective action taken, 15. _ Manufacturers shall have a system for recording and reporting of incidents and feld safety corrective actions as described in Articles 87 and 88,