(1)

In accordance with Article 5(1) of Council Directive 90/385/EEC (2), Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of active implantable medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union.

(2)

By letters BC/CEN/CENELEC/09/89 of 19 December 1991, M/023 - BC/CEN/03/023/93-08 of 5 August 1993 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 90/385/EEC.

(3)

On the basis of request M/023 - BC/CEN/03/023/93-08, CEN revised the harmonised standards EN ISO 10993-16:2010, EN ISO 11607-1:2009 and EN ISO 11737-2:2009, the references of which have been published by Commission Implementing Decision (EU) 2020/438 (3). That revision resulted in the adoption of the harmonised standards EN ISO 10993-16:2017 on biological evaluation of medical devices, EN ISO 11607-1:2020 on packaging for terminally sterilised medical devices and EN ISO 11737-2:2020 on sterilisation of health care products.

(4)

On the basis of request BC/CEN/CENELEC/09/89, CEN revised the harmonised standard EN ISO 10993-18:2009, the reference of which has been published by Implementing Decision (EU) 2020/438. That revision resulted in the adoption of the harmonised standard EN ISO 10993-18:2020 on biological evaluation of medical devices.

(5)

On the basis of request M/295, CEN revised the harmonised standard EN ISO 14155:2011, as corrected by EN ISO 14155:2011/AC:2011, the references of which have been published by Implementing Decision (EU) 2020/438. That revision resulted in the adoption of the harmonised standard EN ISO 14155:2020 on clinical investigation of medical devices for human subjects.

(6)

On the basis of request M/023 - BC/CEN/03/023/93-08, CEN drafted the harmonised standard EN ISO 11607-2:2020 on packaging for terminally sterilised medical devices.

(7)

The Commission together with CEN has assessed whether the harmonised standards drafted and revised by CEN comply with the relevant requests.

(8)

The harmonised standards EN ISO 10993-16:2017, EN ISO 10993-18:2020, EN ISO 11607-1:2020, EN ISO 11607-2:2020, EN ISO 11737-2:2020 and EN ISO 14155:2020 satisfy the requirements which they aim to cover and which are set out in Directive 90/385/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

(9)

It is necessary to replace the references of harmonised standards EN ISO 10993-16:2010, EN ISO 10993-18:2009, EN ISO 11607-1:2009, EN ISO 11737-2:2009 and EN ISO 14155:2011 as corrected by EN ISO 14155:2011/AC:2011, published by Implementing Decision (EU) 2020/438, as those standards have been revised.

(10)

Annex I to Implementing Decision (EU) 2020/438 lists the references of harmonised standards drafted in support of Directive 90/385/EEC. In order to ensure that the references of harmonised standards drafted in support of Directive 90/385/EEC are listed in one act, the reference of standard EN ISO 11607-2:2020 should be included in that Implementing Decision.

(11)

Implementing Decision (EU) 2020/438 should therefore be amended accordingly.

(12)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,