Article 5Surveillance and monitoring
1
For the purpose of surveillance, the F3Secretary of State shall assess an appropriate number of F2approved body’s reviews of the manufacturer’s clinical evaluations and shall carry out an appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:
a
at least every 12 months for F2approved bodies with more than 100 clients;
b
at least every 18 months for all other F2approved bodies.
That designating authority shall, in particular, examine changes which have occurred since the last assessment and the work the F2approved body has performed since that assessment.
F1By way of derogation from the first and second subparagraphs, in exceptional circumstances relating to the COVID-19 pandemic that temporarily prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits, it shall carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the F2approved body’s reviews of the manufacturer’s technical documentation, including clinical evaluations. F4The Secretary of State shall examine changes to the organisational and general requirements set out in Annex II that have occurred since the last on-site assessment and the activities the F2approved body has performed thereafter.
2
Surveillance and monitoring conducted by the F5Secretary of State shall appropriately address subsidiaries.
3
F6The Secretary of State shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. The Secretary of State shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from outside the United Kingdom, which might indicate the non-fulfilment of the obligations by an approved body or its deviation from common or best practice.
In addition to surveillance or renewal on-site assessments, the F7Secretary of State shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed to verify compliance.