Article 8
Use of harmonised standards

1.   Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.

The first subparagraph  shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).

References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.

2.   References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.

Article 9
Common specifications

1.   Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG(Medical Device Coordination Group), 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 II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).在不損害第1條第2款和第17條第5款以及這些規定中規定的期限的前提下，不存在統一標准或相關統一標準不足，或需要解決公共衛生問題時，委員會在徵詢了MDCG（醫療器械協調小組）的意見後，可以通過實施法案，就附件I所列的一般安全和性能要求採用通用規範（CS），並在附錄I列出的技術文檔中採用該規範。附件II和III，附件XIV中規定的臨床評估和上市後臨床隨訪或附件XV中規定的有關臨床研究的要求。那些實施行為應按照第114條第3款規定的審查程序通過。

2.   Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.假定符合第1款所述CS的設備符合該CS或這些CS的相關部分所涵蓋的本法規的要求。

3.   Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.製造商應遵守第1款中提到的CS，除非他們有充分理由證明他們已採用確保安全和性能至少與之等效的解決方案。

4.   Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.儘管有第3款的規定，附件XVI中所列產品的製造商仍應遵守這些產品的相關CS。