NANDO is richer for a new MDR accredited Notified Body, which brings us to 13 certification bodies designated under the new Regulation:
MDC MEDICAL DEVICE CERTIFICATION GMBH
Country : Germany
Phone : +49:711:253597 0
Fax : +49:711:253597 10
Email : firstname.lastname@example.org
Website : http://www.mdc-ce.de
Notified Body number : 0483
The scope can be found on the following link.
Today, the MDCG also issued a guidance document on regulatory requirements for ventilators and others accessories.
In the first part of the document, different types of devices are enlisted and there is a specific section on the classification, both under the current MDD system, as well as under the MDR, namely:
”The rules of classification specified in Annex VIII to the MDR apply. Breathing support devices may be classified to class IIa or IIb (rule 12) or class III (rule 22) if they integrate or incorporate diagnostic functions which significantly determine the patient management by the device, such as closed loop systems.”
After the section on the conformity assessments routes, the MDCG proposes and further explains below regulatory options for placing ventilators on the EU market in the context of the COVID-19 outbreak:
- Producers supplying parts or components to medical devices manufacturers currently placing on the market ventilators
- Producers manufacturing the ventilator itself for the medical device manufacturer currently placing on the market ventilators
- National derogation clauses:
- By amendment of 23 April 2020, Article 59(1) of Medical Devices Regulation (EU) 2017/745 (MDR) empowers Member States to adopt national derogations under both the MDD and the MDR from the date of entry into force of that amendment (24 April 2020).
- Please note that a national derogation can be extended to the whole Union territory by the Commission implementing act (for limited time!)
- ”Timing to obtain a national derogation by a competent authority will greatly depend on the quality and adequacy of the evidence provided by the manufacturer. When technical documentation and evidence of safety of performance is adequate, this can be a feasible option to ensure short-term supply.”
- Medical devices manufacturers’ not currently producing ventilators request an extension of their product range
- Ventilator manufactured entirely by a producer that is not currently a legal manufacturer under the MDD
Follow our News section for all the updates on the MDR/IVDR developments!